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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 269-072-0 | CAS number: 68187-11-1 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77343.
- 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
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- sub-chronic toxicity: inhalation
- Data waiving:
- other justification
- Justification for data waiving:
- other:
- Justification for type of information:
- A 90-day inhalation toxicity study is ongoing with the analogue substance cobalt zinc aluminate blue spinel. An analogue read-across to the substance cobalt zinc aluminate blue spinel has been proposed.
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
According to the ECHA Guidance Read-Across Assessment Framework (RAAF, March 2017), the read-across hypothesis for systemic effects is based on the assumption that different compounds give rise to the same common moieties (“(Bio)transformation to common compound(s)”) to which the organisms are exposed.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
The target substance Cobalt chromite blue green spinel is a complex inorganic colored pigment (CICP) and and for the time being considered to be a mono-constituent substance under REACH. Following the sector specific guidance for complex inorganic colored pigments (Eurocolour, 2017) Cobalt chromite blue green spinel will be considered as an UVCB and will be renamed to cobalt chromium aluminium zinc spinel. Cobalt and chromium expressed as the respective oxides are the main contributing elements. It is noted, that during the manufacture of CICPs chemical bonds of the raw materials are broken, and atoms are homogeneously and ionically interdiffused to form a specific crystalline matrix. Therefore, metals and oxygen atoms occupy specific places within the crystalline lattice, and individual oxides do not exist.
A detailed characterisation of the target substance is given in the attached justification document, Table 1..
The source substance Cobalt zinc aluminate blue spinel is also a complex inorganic colored pigment (CICP) and for the time being considered to be a mono-constituent substance under REACH. Following the sector specific guidance for complex inorganic colored pigments (Eurocolour, 2017) Cobalt zinc aluminate blue spinel will be considered as an UVCB and will be renamed to Cobalt zinc aluminate spinel. It consists of almost the same contributing elements (Cobalt, zinc and aluminium expressed, as oxides are the main constituent). It is noted, that during the manufacture of CICPs chemical bonds of the raw materials are broken, and atoms are homogeneously and ionically interdiffused to form a specific crystalline matrix. Therefore, metals and oxygen atoms occupy specific places within the crystalline lattice, and individual oxides do not exist.
A detailed characterisation of the sourcesubstance is given in the attached justification document, Table 2.
The common characteristic of the target substance and the source substance is that both substances crystallise in the spinel structure, which forms a strong and inert crystal lattice. Both substances consist of almost the same chemical constituents. Furthermore, both show a similar, very low solubility in different artificial and aqueous media which is used for (eco)toxicological predictions.
3. ANALOGUE APPROACH JUSTIFICATION
Upon uptake of the target substance, the toxicological units will be liberated in the ionic form similar to the source substance, which also liberates the toxicological units, cobalt, aluminium and zinc, respectively. Upon solvation in body-fluids such as gastric juice, the toxic units become indistinguishable. The sole relevant modifier of systemic toxicity is the “solubility” of the cations in the respective body-fluid. The target substance also releases trivalent chromium ions which are not known to show signs of systemic toxicity (EFSA, 2014).
The target as well as the source substance show a very low solubility in different artificial and aqueous media demonstrating the inertness of the substances. The source substance shows slightly higher bioaccessibility without showing any signs of systemic or local toxicity in various studies (acute inhalation, sub-acute oral toxicity, skin/eye irritation and sensitisation). The target substance shows no systemic or local toxicity in an acute inhalation, skin/eye irritation or sensitisation study.
Particle size information of the substance influences the deposition behaviour in the respiratory tract and potential toxic effects. Based on particle size distribution data, trends in deposition and potency of effects can be assessed for locally acting substances.
When comparing the particle size and the MMAD obtained in the acute inhalation toxicity studies of the two substances one can assume that the deposition behaviour of both pigments is comparable. This is further emphasised by the results of the MPPD model, where about 1.5 % or less of inhaled material is predicted to be deposited in the pulmonary region (PU) for both pigments. Most of the material of both pigments deposited in the tracheobronchial (TB) and the extrathoracic region (Head) and may be assumed to be cleared to the GI tract (i. e., by mucociliary escalation and subsequent swallowing). Furthermore, taking into account that the source substance shows slightly higher bioaccessibility in artificial lung fluids (ALF and GMB) read-across can be considered to be conservative.
4. DATA MATRIX
A data matrix is presented in Appendix 1 of the attached justification document.
A detailed read-across justification is provided in the attached document.
Data source
Materials and methods
Results and discussion
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
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.