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EC number: 269-075-7 | CAS number: 68187-15-5 An inorganic pigment that is the reaction product of high temperature calcination in which praseodymium (III) oxide, praseodymium (IV) oxide, silicon oxide, and zirconium (IV) oxide in varying amounts are homogeneously and ionically interdiffused to form a crystalline matrix of zircon. Its composition may include any one or a combination of the modifiers alkali or alkaline earth halides.
- 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
Long-term toxicity to aquatic invertebrates
Administrative data
- Endpoint:
- long-term toxicity to aquatic invertebrates
- Data waiving:
- study technically not feasible
- Justification for data waiving:
- other:
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
Zirconium praseodymium yellow zircon can be considered environmentally and biologically inert due to the characteristics of the synthetic process (calcination at a high temperature of approximately 1000°C), rendering the substance to be of a unique, stable crystalline structure in which all atoms are tightly bound and not prone to dissolution in environmental and physiological media. This assumption is supported by available transformation/dissolution data (Grane, 2010) that indicate a very low release of pigment components. Transformation/dissolution of zirconium praseodymium yellow zircon (24-screening test according to OECD Series 29, loading of 100 mg/L) resulted in mean dissolved praseodymium concentrations of 3.05 µg/L Pr and 21.66 µg/L Pr, silicon concentrations of 0.13 µg/L Si and 0.02 µg/L Si at pH 6 and 8, respectively, whereas dissolved zirconium concentrations remained below the LOD (< 0.08 µg/L Zr). Since silicon does not have an ecotoxic potential, as confirmed by the absence of respective ecotoxicity reference values in the Metals classification tool (MeClas) database, and the dissolution of praseodymium is highest at pH 6, pH 6 is considered as pH that maximised metal release. Metal release at the 1 mg/L loading and pH 6 resulted in dissolved concentrations of 2.10 µg/L Pr and 0.17 µg/L Zr after 7 days and 0.79 µg/L Pr and < 0.08 µg/L Zr (< LOD) after 28 days whereas silicon concentrations remained below the LOD (< 0.07 µg/L Si) during the test. Thus, the rate and extent to which zirconium praseodymium yellow zircon produces soluble (bio)available ionic and other praseodymium-, silicon- or zirconium-bearing species in environmental media is limited. Hence, the pigment can be considered as environmentally and biologically inert during short- and long-term exposure. The poor solubility of zirconium praseodymium yellow zircon is expected to determine its behaviour and fate in the environment, and subsequently its potential for ecotoxicity.
Reliable proprietary studies are not available for zirconium praseodymium yellow zircon. The poorly soluble substance zirconium praseodymium yellow zircon is evaluated by comparing the dissolved metal ion levels resulting from the transformation/dissolution test after 28 days at a loading rate of 1 mg/L with the lowest chronic ecotoxicity reference values (ERVs) as determined for the (soluble) metal ions. The ERVs are based on the lowest NOEC/EC10 values for algae, invertebrates and fish. Chronic ERVs were obtained from the Metals classification tool (MeClas) database as follows: Hazard information for praseodymium is not included in the MeClas database. Nevertheless, soluble praseodymium salts (Praseodymium trichloride, EC 233-794-4, CAS 10361-79-2; Praseodymium trinitrate, EC 233-796-5, CAS 10361-80-5) are self-classified as Aquatic Chronic 1 (M-factor 1) indicative of a NOEC/EC10 of > 0.01 ≤ 0.1 mg/L (https://echa.europa.eu/information-on-chemicals/cl-inventory-database, accessed on 12.03.2021), which is applied to evaluate the aquatic hazard potential of zirconium praseodymium yellow zircon. A chronic ERV for silicon has not been derived since a concern for long-term (chronic) toxicity of silicon ions was not identified (see also OECD, 2004). A chronic ERV has also not been derived for zirconium. Metal release in the T/D test at the 1 mg/L loading and pH 6 resulted in dissolved concentrations of 0.79 µg/L Pr and < 0.08 µg/L Zr (< LOD) after 28 days, whereas silicon concentrations remained also below the LOD (< 0.07 µg/L Si). Due to the lack of an aquatic hazard potential for silicon and zirconium ions and the fact that dissolved praseodymium concentrations were well below the respective NOEC/EC10 estimate of > 0.01 ≤ 0.1 mg/L, it can be concluded that the substance zirconium praseodymium yellow zircon is not sufficiently soluble to cause long-term toxicity at the level of the chronic ERVs (expressed as NOEC/EC10).
In accordance with Figure IV.5 „Classification strategy for determining long-term aquatic hazard for metal compounds “of ECHA Guidance on the Application of the CLP Criteria (Version 5.0, July 2017) and section 4.1.2.10.2. of Regulation (EC) No 1272/2008, the substance zirconium praseodymium yellow zircon is poorly soluble and does not meet classification criteria for chronic (long-term) aquatic hazard.
In accordance with Annex XI, Section 2 of Regulation (EC) 1907/2006, “Testing for a specific endpoint may be omitted, if it is technically not possible to conduct the study as a consequence of the properties of the substance”.
Zirconium praseodymium yellow zircon is poorly soluble and unlikely to cross biological membranes. Hence, zirconium praseodymium yellow zircon can be considered environmentally and biologically inert during aquatic exposure (please see above). For a highly insoluble substance such as zirconium praseodymium yellow zircon, it may neither be possible nor relevant to try and conduct aquatic toxicity tests, as it is difficult to maintain a quantifiable and constant concentration of the substance in the environmental test medium. In accordance with the generic testing recommendations in the “Executive summary of the MISA 2 workshop (https://echa.europa.eu/misa)” for difficult to test substances, “The Water Accommodated Fraction (WAF) method (see REACH and OECD guidance on difficult to test substances), should not be used for metals. The reason is that this method often uses nominal loadings and lacks the pH and surface relationships necessary to estimate the potential hazard. Direct aquatic ecotoxicity testing of metals and SSMCs is in principle not recommended. However, if used or needed (e.g. for complex materials like UVCBs) then it should be conducted based on the dissolved fraction(s) of the T/D medium, at the appropriate pH (pH that dilutes the most).”
Since the substance zirconium praseodymium yellow zircon is not sufficiently soluble to cause long-term toxicity at the level of the chronic ERVs (expressed as NOEC/EC10), it is neither technically possible in accordance with Annex XI, Section 2 of Regulation (EC) 1907/2006 nor scientifically justified to conduct any further aquatic toxicity study, including long-term toxicity to invertebrates with zirconium praseodymium yellow zircon.
References:
OECD (2004) SIDS Initial Assessment Profile Silicon dioxide, Silicic acid, aluminum sodium salt, Silicic acid, calcium salt. SIAM 19, 19-22 October 2004.
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
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