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Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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EC number: 931-895-4 | 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- no data available
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Hypothesis for read-across: Cobalt dihydroxide and nickel dihydroxide are the main components of the target UVCB-substance, and considered the major drivers for adverse effects based on its properties and relative quantity in the substance. For read-across purpose, available data from cobalt and nickel compounds are considered relevant for the target UVCB-substance in the REACH registration. Compareable to guideline study (In the original guideline 406, four adjuvant tests were considered to be acceptable. The GPMT which uses adjuvant is given preference over other methods) with acceptable restrictions.
Data source
Reference
- Reference Type:
- publication
- Title:
- Modified short-term guinea pig sensitization tests for detecting contact allergens as an alternative to the conventional test.
- Author:
- Yanagi, M.; et. al.
- Year:
- 2 001
- Bibliographic source:
- Contact Derm. 44, 140-145
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- ; Purity of test substance is not given. No positive control was used. Number of test animals is to small (5 instead of the required minimum of 10 animals).
- GLP compliance:
- not specified
- Type of study:
- other: Adjuvant and patch test (APT)
Test material
- Reference substance name:
- Cobalt sulphate
- EC Number:
- 233-334-2
- EC Name:
- Cobalt sulphate
- Cas Number:
- 10124-43-3
- IUPAC Name:
- cobalt(2+) sulfate
- Reference substance name:
- cobalt(II) sulfate
- IUPAC Name:
- cobalt(II) sulfate
- Details on test material:
- - Name of test material (as cited in study report): cobalt sulfate
- Molecular formula (if other than submission substance): CoSO4
- Molecular weight (if other than submission substance): 154.996 g/mol (anhydrous)
- Physical state: solid
No further details are given.
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Japan SLC Inc.
- Weight at study initiation: 380 to 500 g
- Housing: The animals were housed individually in a stainless steel cage.
- Diet: ad libitum; pellet diet
- Water: ad libitum; sterilised water
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +/- 3
- Humidity (%): 55 +/- 15
- Photoperiod: 12 hours dark/light cycle
No further details are given.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- Induction: 3%
Challenge: 0.01%, 0.03%, 0.1%, 0.3%, 1% and 3%
Challengeopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- water
- Concentration / amount:
- Induction: 3%
Challenge: 0.01%, 0.03%, 0.1%, 0.3%, 1% and 3%
- No. of animals per dose:
- 5 animals were distributed to both sensitising and control groups with all chemicals.
- Details on study design:
- RANGE FINDING TESTS: No data available, if a prelimninary study was performed.
MAIN STUDY
I) Adjuvant and patch test (APT)
A. INDUCTION EXPOSURE
- No. of exposures: 4 exposures: after one intradermal injection of 0.1 mL emulsified FCA (E-FCA) on the 1st day, test material was applied occlusively for 24 hours; 2 further occlusive applications for the following 2 days. And on the 9th day, 0.2 mL of the test material was applied occlusively for 48 hours.
- Exposure period: from day 1 to day 3
- Control group: vehicle control
- Site: at the 4 corners of a clipped and shaved 2x4 cm² nuchal area
- Frequency of applications: every 24 hours
- Concentrations: 3%
B. CHALLENGE EXPOSURE
- No. of exposures: On the 21st day after initial induction, 0.01 mL aliquots of various concentrations of the test material in the vehicle were applied for challenge.
- Day(s) of challenge: 1
- Control group: vehicle control
- Site: shaved area of the flank of each animal
- Concentrations: 0.01-3%
- Evaluation (hr after challenge): Observations were done 24 and 48 hours after challenge.
OTHER: Assessment of skin reaction: A score greater than 1 was considered as positive.Table with scoring system is attached. - Challenge controls:
- no further details
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- no data
Any other information on results incl. tables
Sensitisation rate of CoSO4:
- 0.01% test material: 40% sensitisation
- 0.03% to 3.0% test material: 100% sensitisation
Justification for read-across: Cobalt dihydroxide and nickel dihydroxide are the main components of the target UVCB-substance, and considered the major drivers for adverse effects based on its properties and relative quantity in the substance. For read-across purpose, available data from cobalt and nickel are considered relevant for the target UVCB-substance in the REACH registration. According to section 1.5, annex XI of regulation (EC) 1907/2006, such studies do not need to be conducted, since adequate data from structurally analogous substances are available. Therefore read-across from these compounds is justified.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information At a concentration of 0.01% test material, a sensitisation rate of 40% was determined. At concentrations between 0.03-3% CoSO4, a sensitisation rate of 100% was determined.
- Conclusions:
- Under the test condition reported, cobalt sulfate has sensitising potential.
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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