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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 233-254-8 | CAS number: 10101-58-3
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Fully Guideline- and GLP-compliant
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Directive 2001/59/EC (6 August 2001)
- Qualifier:
- according to guideline
- Guideline:
- other: OECD-Guideline 437, "Bovine Corneal Opacity and Permeability Test Method (BCOP) ", 07 September 2009
- Qualifier:
- according to guideline
- Guideline:
- other: EPA (1996) EPA737-B-96-001
- Qualifier:
- according to guideline
- Guideline:
- other: UN (2007) GHS
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4-amino-2-methylpyrimidine-5-methylamine
- EC Number:
- 202-384-7
- EC Name:
- 4-amino-2-methylpyrimidine-5-methylamine
- Cas Number:
- 95-02-3
- IUPAC Name:
- 5-(aminomethyl)-2-methylpyrimidin-4-amine
- Details on test material:
- Name of test material (as cited in study report): Cobalt wolframate
Chemical name: Cobalt wolframate
Molecular formula: CoWO4
Batch No.: 750702_20100329
CAS No.: 10101-58-3
Appearance: Darb blue powder
Solubility: Not soluble in water.
pH: -
Conditions of storage: At room temperature.
Stability at conditions of storage: Stable.
Date of expiry: 31 May 2015
Constituent 1
Test animals / tissue source
- Species:
- other: invitro
- Details on test animals or tissues and environmental conditions:
- Eyes were collected by slaughterhouse employees and were enucleated as soon as possible after death. To prevent exposure of the eyes to potentially irritant substances, the slaughterhouse employees did not use detergent when rinsing the head of the animal.
Eyes were immersed completely in cold HBSS+ in a container. To minimize the risk of contamination 100 IU/ml penicillin and streptomycin was added to the HBSS and for transport the container was kept in a cold box with cooling packs.
Collection of the eyes and use of corneas occured on the same day. The time interval between collection and use was kept as short as possible and recorded. All eyes used in the assay were from the same group of animals of one slaughterhouse.
After arrival at the laboratory, the eyes were carefully visually examined for defects including increased opacity, scratches and neovascularization. Only corneas from eyes free of such defects were used. All corneas were dissected with a 2 to 3 mm rim of sclera with care to avoid damage to the corneal epithelium and endothelium. Isolated corneas were mounted in cornea holders that consist of anterior and posterior compartments, which interface with the epithelial and endothelial sides of the cornea. Both chambers (posterior chamber first) were filled with pre-warmed cEMEM. The device was then equilibrated at 32 °C +/-1 °C for at least one hour in an air incubator to achieve normal metabolic activity.
Test system
- Vehicle:
- water
- Amount / concentration applied:
- The test substance was administered at a concentration of 20 % (w/v) in deionised water (sterile). The test substance preparation was a suspension.
- Duration of treatment / exposure:
- Bovine Corneal Opacity and Permeability Test Method:
• 1 hour equilibration
• 4 hours test substance incubation
• 1.5 hours fluorescein incubation - Observation period (in vivo):
- n.a
- Number of animals or in vitro replicates:
- Three cornas were used for each treatment (test substance, negative and positive control). As negative control deionised sterile water and as positive control 20% Imidazole were used.
- Details on study design:
- Bovine corneas were isolated and mounted in cornea holders and equilibrated for one hour (at 31.1 °C – 33.0 °C) to achieve normal metabolic activity. After exclusion of corneas which did not achieve quality criteria, the corneas were distributed into groups (3 per group) and exposed to 750 µl test substance preparation (suspension), the negative control and the positive control for 4 hours. Incubation temperature was 31.1 °C – 33.0 °C. After the exposure period substances were removed from the anterior chamber and the epithelium was washed eight times with EMEM+ to determine the effectiveness of rinsing acidic or alkaline materials and to remove substance residues. cEMEM was used as a final rinse to ensure removal of the phenol red from the anterior chamber prior to the opacity measurement. Both chambers were then refilled with fresh cEMEM. Opacity was determined by the amount of light transmission through the cornea. Corneal opacity was measured quantitatively in Lux with the aid of an opacitometer-kit BASF-OP2.0, which was calibrated with a standard filter set before the corneas were measured. 1 ml sodium fluorescein solution was added to the anterior chamber of the cornea holder and then incubated in a horizontal position for 90 minutes. Incubation temperature was 31.1 °C – 33.0 °C. Permeability was determined by the amount of sodium fluorescein dye that penetrated all corneal cell layers. The amount of sodium fluorescein that crossed into the posterior chamber was quantitatively measured with the aid of a Bio-Tek EL800 microtiter plate reader at 490 nm. For measurement 360 µl of cEMEM from the posterior chamber were transferred into the wells of a 96-well microtiter plate (triplicates). Data were recorded as OD490 values which were equivalent to the OD490 values based upon a visible light spectrophotometer using a standard 1 cm path length. To proof that the measurement was performed in the linear range wells containing 8 concentrations (ranging from 12.5 µg/ml to 0.78 µg/ml) of fluorescein solutions were additionally prepared.
Results and discussion
In vivo
Results
- Irritation parameter:
- other: Mean IVIS
- Basis:
- mean
- Time point:
- other: Endpoint
- Score:
- 17
- Reversibility:
- other: n.a
- Remarks on result:
- other: not an ocular corrosive or severe irritant
- Irritant / corrosive response data:
- The mean IVIS of the three substance treated bovine corneas was 17.0.
The mean IVIS of the three negative control treated bovine corneas was 3.3.
The mean IVIS of the three positive control treated bovine corneas was 105.8. - Other effects:
- Assay acceptance criteria according to the OECD Guideline 437:
• The mean IVIS of the three negative control treated bovine corneas was 3.3. This study met the acceptance critera because the mean opacity and the mean permeability of the corneas, treated with deionised water (NC) were 3.3 and 0.000 respectively, are less than the established upper limits for background opacity and permeability values of the historical data of the negative controls.
• The mean IVIS of the three positive control treated bovine corneas was 105.8. This study met the acceptance criteria because the mean IVIS of the corneas, treated with 20 % imidazole (PC) was 105.8, is within the range of the historical data.
The validity of the opacitometer is given since the measurements of the control filters were within the range of the historical data. The validity of the cornea holder is given because the cornea holder control value Io was within the range of the historical data. The correlation coefficient of the fluorescein dilutions was 0.9999. Since the correlation coefficient was > 0.99 the linearity was given.
Applicant's summary and conclusion
- Interpretation of results:
- other: not an ocular corrosive or severe irritant
- Remarks:
- Criteria used for interpretation of results: other: OECD Guideline 437
- Conclusions:
- According to the results of this study the test substance
"Cobalt wolframate" is considered to be not an ocular corrosive or severe irritant.
According to the results of this study and the Directive 2001/59/EC for classification, the test substance "Cobalt wolframate" requires further testing as outlined in the OECD guideline 405. - Executive summary:
Aim and Method
The study was performed to evaluate possible ocular corrosion and severe irritation of"Cobalt wolframate"according tothe OECD Guideline 437 for the testing of chemicals “Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants”,. The BCOP Testhas sufficient accuracy and reliability for the prediction of ocular corrosion or irritancy of test substances.
Bovine corneas are isolated and mounted in cornea holders and equilibrated for at least one hour to achieve normal metabolic activity. After exclusion of corneas which do not achieve certain quality, 3 corneas / substance are distributed into groups and exposed to the test substance, the negative control and the positive control for 4 hours. Then the substances are removed and the corneas are accurately washed. Afterwards the opacity and permeability of each cornea are recorded. Opacity is measured quantitatively with the aid of an opacitometer. Permeability is determined by the amount of sodium fluorescein dye that penetrates all cornea layers. For this purpose fluorescein solution is filled into anterior chamber followed by an incubation for 90 minutes. The amount of sodium fluorescein that crosses into the posterior chamber is quantitatively measured with a spectrophotometer at OD490. Using opacity and permeability data an in vitro irritancy score (IVIS) is calculated. If the IVIS of the controls do not meet the acceptance criteria the study is invalid and will be repeated.
• Investigations performed were in conformance with
OECD-Guideline 437, Bovine Corneal Opacity and Permeability Test Method (BCOP), 7thof September 2009.
“The OECD-Principles of Good Laboratory Practice”, OECD Environment Health and Safety Publications, Series on Principles of Good Laboratory Practice and Compliance Monitoring No. 1,1998.
U.S.EPA (1996). Label Review Manual: 2ndEdition. EPA737-B-96-001.,:Environmental Protection Agency.
EU (2001). Commission Directive 2001/59/EC ofadapting to technical progress for the 28thtime Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances. Official Journal of the European Communities
L255:1-333.UN (2007). Globally Harmonized System of Classification and Labelling of Chemicals (GHS).&: United Nations Publications.
Results
The validity of the opacitometer is given since the measurements of the control filters were within the range of the historical data.
The validity of the cornea holder is given because the cornea holder control value Iowas within the range of the historical data.
The mean opacity and the mean permeability of the corneas, treated with deionised water (NC) were 3.3 and 0.000 respectively, which are less than the established upper limits for background opacity and permeability values of the historical data of the negative controls.
The mean IVIS of the corneas, treated with 20 % imidazole (PC) was 105.8, which is within the range of the historical data.
The control substances were in the required ranges, thus demonstrating the validity of the experiment.
Thecorrelation coefficientof the fluorescein dilutions was0.9999. Since the correlation coefficient was > 0.99 the linearity was given.
CONCLUSION
The IVIS of"Cobalt wolframate"was 17.1. Furthermore, no important increase in opacity and no increase in permeability was observed.
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.