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EC number: - | 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
Short-term toxicity to aquatic invertebrates
Administrative data
- Endpoint:
- short-term toxicity to aquatic invertebrates
- 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 highly insoluble in water, hence indicating that aquatic toxicity is unlikely to occur
- the study does not need to be conducted because the substance is unlikely to cross biological membranes, hence indicating that aquatic toxicity is unlikely to occur
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
According to Annex VII, Column 2, Section 9.1.1. of Regulation (EC) 1907/2006, testing for short-term toxicity on invertebrates does not need to be conducted if “there are mitigating factors indicating that aquatic toxicity is unlikely to occur, for instance if the substance is highly insoluble in water or the substance is unlikely to cross biological membranes”.
Titanium, iron and aluminium pseudobrookite and rutile 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 transformation/dissolution data (Knopf, 2018) that indicate a very low release of pigment components at pH 6 and 8. Transformation/dissolution tests of titanium, iron and aluminium pseudobrookite and rutile at a loading of 1 mg/L and pH 6 resulted after 7 days in aluminium concentrations below the LOD of 0.161 µg Al/L, iron concentrations of 1.34 µg Fe/L and titanium concentrations below the LOQ of 0.123 µg Ti/L. After 28 days at pH 6 aluminium concentrations remained below the LOD of 0.341 µg Al/L, while the dissolved iron and titanium concentrations amounted to 0.357 µg Fe/L and 0.063 µg Ti/L, respectively. T/D tests at pH 8 resulted after 7 days in dissolved aluminium and iron concentrations below the LODs of 0.161 µg Al/L and 0.035 µg Fe/L, respectively. Titanium concentrations remained below the respective LOQ of 0.123 µg Ti/L. After 28 days at pH 8, the dissolved aluminium concentrations amounted to 0.533 µg Al/L, while the iron concentrations remained below the LOD of 0.085 µg Fe/L and the titanium concentrations below the LOQ of 0.123 µg Ti/L. Thus, the rate and extent to which titanium, iron and aluminium pseudobrookite and rutile produces soluble (bio)available ionic and other aluminium-, iron- and titanium-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 titanium, iron and aluminium pseudobrookite and rutile is expected to determine its behaviour and fate in the environment, and subsequently its potential for ecotoxicity.
Proprietary studies are not available for titanium, iron and aluminium pseudobrookite and rutile. The poorly soluble substance titanium, iron and aluminium pseudobrookite and rutile is evaluated by comparing the dissolved metal ion levels resulting from the transformation/dissolution test after 7 days at a loading rate of 1 mg/L with the lowest acute ecotoxicity reference values (ERVs) as determined for the (soluble) metal ions. The acute ERVs are based on the lowest EC50/LC50 values for algae, invertebrates and fish and were obtained from the Metals classification tool (MeClas) database as follows: The acute ERVs of aluminium (1,040 µg Al/L at pH 6 and 3,390 µg Al/L at pH 8), iron (>100 mg Fe/L) and titanium are above 1 mg/L and a concern for short-term (acute) toxicity was not identified (no classification). According to ECHA Guidance on the Application of the CLP Criteria (Version 5.0, July 2017), “Where the acute ERV for the metal ions of concern is greater than 1 mg/L the metals need not be considered further in the classification scheme for acute hazard.” Due to the lack of an acute aquatic hazard potential of aluminium, iron and titanium ions and the fact that almost all dissolved metal concentrations, except the dissolved iron concentration at pH 6 (1.34 µg Fe/L), remained below the respective LODs (< 0.161 µg Al/L, < 0.035 µg Fe/L) or LOQs (< 0.123 µg Ti/L) after 7 days T/D tests at pH 6 and 8, it can be concluded that the substance titanium, iron and aluminium pseudobrookite and rutile is not sufficiently soluble to cause short-term toxicity at the level of the acute ERVs (expressed as EC50/LC50).
In accordance with Figure IV.4 “Classification strategy for determining acute 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 titanium, iron and aluminium pseudobrookite and rutile is poorly soluble and does not meet classification criteria for acute (short-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”.
Titanium, iron and aluminium pseudobrookite and rutile is poorly soluble and unlikely to cross biological membranes. Hence, Titanium, iron and aluminium pseudobrookite and rutile can be considered environmentally and biologically inert during aquatic exposure (please see above). For a highly insoluble substance such as Titanium, iron and aluminium pseudobrookite and rutile, 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 Titanium, iron and aluminium pseudobrookite and rutile is not sufficiently soluble to cause short-term toxicity at the level of the acute ERVs (expressed as EC/LC50), it is not technically possible in accordance with Annex XI, Section 2 of Regulation (EC) 1907/2006 to conduct any further aquatic toxicity study, including short-term toxicity to invertebrates with Titanium, iron and aluminium pseudobrookite and rutile.
Titanium, iron and aluminium pseudobrookite and rutile is poorly soluble and unlikely to cross biological membranes. In accordance with Annex VII, Column 2, Section 9.1.1. of Regulation (EC) 1907/2006, testing for short-term toxicity to invertebrates is not necessary.
Cross-reference
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint:
- transformation / dissolution of metals and inorganic metal compounds
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017-08-08 to 2017-10-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Series on Testing and Assessment No. 29 (23-Jul-2001): Guidance document on transformation/dissolution of metals and metal compounds in aqueous media
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- signed 2016-05-31
- Type of method:
- flask method
- Key result
- Type of test:
- full transformation/dissolution test - metals and sparingly soluble metal compounds
- Mean dissolved conc.:
- < 0.341 µg/L
- Element analysed:
- Al
- Loading of aqueous phase:
- 1 mg/L
- Incubation duration:
- 28 d
- Test conditions:
- pH = 6, separation of solid phase by filtration 0.2 µm
- Remarks on result:
- other:
- Remarks:
- conc. of all replicates < LOD: 0.341 µg/L
- Key result
- Type of test:
- full transformation/dissolution test - metals and sparingly soluble metal compounds
- Mean dissolved conc.:
- 0.533 µg/L
- Element analysed:
- Al
- Loading of aqueous phase:
- 1 mg/L
- Incubation duration:
- 28 d
- Test conditions:
- pH = 8, separation of solid phase by filtration 0.2 µm
- Key result
- Type of test:
- full transformation/dissolution test - metals and sparingly soluble metal compounds
- Mean dissolved conc.:
- < 0.161 µg/L
- Element analysed:
- Al
- Loading of aqueous phase:
- 1 mg/L
- Incubation duration:
- 7 d
- Test conditions:
- pH = 6, separation of solid phase by filtration 0.2 µm
- Remarks on result:
- other:
- Remarks:
- conc. of all replicates < LOD: 0.161 µg/L
- Key result
- Type of test:
- full transformation/dissolution test - metals and sparingly soluble metal compounds
- Mean dissolved conc.:
- < 0.161 µg/L
- Element analysed:
- Al
- Loading of aqueous phase:
- 1 mg/L
- Incubation duration:
- 7 d
- Test conditions:
- pH = 8, separation of solid phase by filtration 0.2 µm
- Remarks on result:
- other:
- Remarks:
- conc. of all replicates < LOD: 0.161 µg/L
- Type of test:
- full transformation/dissolution test - metals and sparingly soluble metal compounds
- Mean dissolved conc.:
- < 0.161 µg/L
- Element analysed:
- Al
- Loading of aqueous phase:
- 1 mg/L
- Incubation duration:
- 24 h
- Test conditions:
- pH = 6, separation of solid phase by filtration 0.2 µm
- Remarks on result:
- other:
- Remarks:
- conc. of all replicates < LOD: 0.161 µg/L
- Type of test:
- full transformation/dissolution test - metals and sparingly soluble metal compounds
- Mean dissolved conc.:
- < 0.161 µg/L
- Element analysed:
- Al
- Loading of aqueous phase:
- 1 mg/L
- Incubation duration:
- 24 h
- Test conditions:
- pH = 8, separation of solid phase by filtration 0.2 µm
- Remarks on result:
- other:
- Remarks:
- conc. of all replicates < LOD: 0.161 µg/L
- Key result
- Type of test:
- full transformation/dissolution test - metals and sparingly soluble metal compounds
- Mean dissolved conc.:
- 0.357 µg/L
- Element analysed:
- Fe
- Loading of aqueous phase:
- 1 mg/L
- Incubation duration:
- 28 d
- Test conditions:
- pH = 6, separation of solid phase by filtration 0.2 µm
- Key result
- Type of test:
- full transformation/dissolution test - metals and sparingly soluble metal compounds
- Mean dissolved conc.:
- < 0.085 µg/L
- Element analysed:
- Fe
- Loading of aqueous phase:
- 1 mg/L
- Incubation duration:
- 28 d
- Test conditions:
- pH = 8, separation of solid phase by filtration 0.2 µm
- Remarks on result:
- not determinable
- Remarks:
- not distinguishable from blank
- Key result
- Type of test:
- full transformation/dissolution test - metals and sparingly soluble metal compounds
- Mean dissolved conc.:
- 1.34 µg/L
- Element analysed:
- Fe
- Loading of aqueous phase:
- 1 mg/L
- Incubation duration:
- 7 d
- Test conditions:
- pH = 6, separation of solid phase by filtration 0.2 µm
- Key result
- Type of test:
- full transformation/dissolution test - metals and sparingly soluble metal compounds
- Mean dissolved conc.:
- < 0.035 µg/L
- Element analysed:
- Fe
- Loading of aqueous phase:
- 1 mg/L
- Incubation duration:
- 7 d
- Test conditions:
- pH = 8, separation of solid phase by filtration 0.2 µm
- Remarks on result:
- other:
- Remarks:
- conc. of all replicates < LOD: 0.035 µg/L
- Type of test:
- full transformation/dissolution test - metals and sparingly soluble metal compounds
- Mean dissolved conc.:
- < 0.035 µg/L
- Element analysed:
- Fe
- Loading of aqueous phase:
- 1 mg/L
- Incubation duration:
- 24 h
- Test conditions:
- pH = 6, separation of solid phase by filtration 0.2 µm
- Remarks on result:
- other:
- Remarks:
- conc. of replicates < LOD: 0.035 µg/L
- Type of test:
- full transformation/dissolution test - metals and sparingly soluble metal compounds
- Mean dissolved conc.:
- < 0.035 µg/L
- Element analysed:
- Fe
- Loading of aqueous phase:
- 1 mg/L
- Incubation duration:
- 24 h
- Test conditions:
- pH = 8, separation of solid phase by filtration 0.2 µm
- Remarks on result:
- other:
- Remarks:
- conc. of all replicates < LOD: 0.035 µg/L
- Key result
- Type of test:
- full transformation/dissolution test - metals and sparingly soluble metal compounds
- Mean dissolved conc.:
- 0.063 µg/L
- Element analysed:
- Ti
- Loading of aqueous phase:
- 1 mg/L
- Incubation duration:
- 28 d
- Test conditions:
- pH = 6, separation of solid phase by filtration 0.2 µm
- Key result
- Type of test:
- full transformation/dissolution test - metals and sparingly soluble metal compounds
- Mean dissolved conc.:
- < 0.123 µg/L
- Element analysed:
- Ti
- Loading of aqueous phase:
- 1 mg/L
- Incubation duration:
- 28 d
- Test conditions:
- pH = 8, separation of solid phase by filtration 0.2 µm
- Remarks on result:
- other:
- Remarks:
- conc. of all replicates at least < LOQ: 0.123 µg/L
- Key result
- Type of test:
- full transformation/dissolution test - metals and sparingly soluble metal compounds
- Mean dissolved conc.:
- < 0.123 µg/L
- Element analysed:
- Ti
- Loading of aqueous phase:
- 1 mg/L
- Incubation duration:
- 7 d
- Test conditions:
- pH = 6, separation of solid phase by filtration 0.2 µm
- Remarks on result:
- other:
- Remarks:
- conc. of all replicates at least < LOQ: 0.123 µg/L
- Key result
- Type of test:
- full transformation/dissolution test - metals and sparingly soluble metal compounds
- Mean dissolved conc.:
- < 0.123 µg/L
- Element analysed:
- Ti
- Loading of aqueous phase:
- 1 mg/L
- Incubation duration:
- 7 d
- Test conditions:
- pH = 8, separation of solid phase by filtration 0.2 µm
- Remarks on result:
- other:
- Remarks:
- conc. of all replicates at least < LOQ: 0.123 µg/L
- Type of test:
- full transformation/dissolution test - metals and sparingly soluble metal compounds
- Mean dissolved conc.:
- 0.103 µg/L
- Element analysed:
- Ti
- Loading of aqueous phase:
- 1 mg/L
- Incubation duration:
- 24 h
- Test conditions:
- pH = 6, separation of solid phase by filtration 0.2 µm
- Type of test:
- full transformation/dissolution test - metals and sparingly soluble metal compounds
- Mean dissolved conc.:
- 0.04 µg/L
- Element analysed:
- Ti
- Loading of aqueous phase:
- 1 mg/L
- Incubation duration:
- 24 h
- Test conditions:
- pH = 8, separation of solid phase by filtration 0.2 µm
- Details on results:
- Solution pH, oxygen concentrations, temperature
The temperature of the thermostatically controlled room was recorded with a data logger. The mean temperature was 21.3 ± 0.3 °C. The solution pH remained relatively constant for the pH 6 treatment for the method blank vessels (6.15 – 6.37) as for the sample vessels (5.93 – 6.37).
Oxygen levels in all test vessels pH 6 were in the range recommended by the OECD Test Guidance 29 during the test: above 70 % of oxygen saturation at 8.5 mg/L (70 % of 8.5 mg/L = 6 mg/L). The solution pH for the pH 8 treatment showed a decrease of the pH during the test in the method blanks as well as in the sample vessels. In the test item vessels the pH was in the range of 7.64 – 7.93 and in method blank vessels the pH was in the range of 7.66 – 7.84. Oxygen levels in all test vessels pH 8 were in the range recommended by the OECD Test Guidance 29 during the test: above 70 % of oxygen saturation at 8.5 mg/L (70 % of 8.5 mg/L = 6 mg/L)
Analytical measurements: Within and between vessel variations of elemental concentrations (Fe, Ti, Al)
Within and between vessel variations are not always in compliance with the guidance for the tests. For these samples the observed variations of > 20 % (between-vessel) or > 10 % (within-vessel) are probably due to the low dissolution and the majority of measurements being close to – or below – the respective quantification limit of the method - Conclusions:
- The transformation/dissolution test (OECD Series on Testing and Assessment Number 29, 2001) of "Titanium, iron and aluminium pseudobrookite and rutile (Pigment Black 12)" at a loading of 1 mg/L at pH 6 and 8, performed for 28d, resulted in maximum quantified Al concentrations of 0.533 µg/L (pH = 8, 28d), maximum Fe concentrations of 0.357 µg/L (pH = 6, 28d) als well as maximum Ti concentrations of 0.063 µg/L (pH = 6, 28d). Thus, the extent to which "Pigment Titanium, iron and aluminium pseudobrookite and rutile (Pigment Black 12)" can produce soluble available ionic and other metal-bearing species in aqueous media is limited.
Method validation summary (ICP-OES)
Limits of detection (LODs), limits of quantification (LOQs) and correlation coefficients (r)
Limits of detection (LOD) within all measurement series: 0.161 -0.341 μg Al / L, 0.035 - 0.085 µg / L Fe
Limits of quantification (LOQ) within all measurement series: 0.482 - 1.02 μg Al / L, 0.106 - 0.255 µg / L Fe
Correlation coefficients (r) within all measurement series: > 0.999926 (Al calibration), > 0.999868 (Fe calibration)
Mean recovery of fortified samples (concentration range 6 - 160 µg, n > 5): 95,2 - 119 % (Al fortification), 95 - 108 % (Fe fortification)
Mean recovery for certified reference material TMDA-52.4 (lot no. 0615, Environment Canada): 99.9 - 104 % (Al measurement, n = 15), 98.4 - 103 % (Fe measurement, n = 13)
date |
Chosen wavelength [nm] |
LOD |
LOQ |
correlation coefficient |
Sum of quality assurance samples |
Recovery of quality assurance samples [%] |
August 17, 2017; measurement of test samples |
Al: 167.019* Fe: 238.204* |
Al: 0.161 Fe: 0.035 |
Al: 0.482 Fe: 0.106 |
Al: 0.999926 Fe: 0.999868 |
Al: 17 Fe: 17 |
Al: 88.2 Fe: 88.2 |
date |
Chosen wavelength [nm] |
LOD |
LOQ |
correlation coefficient |
Sum of quality assurance samples |
Recovery of quality assurance samples [%] |
September 29, 2017; measurement of test samples (28 d) and method blank samples (28 d) |
Al: 167.019* Fe: 238.204* |
Al: 0.341 Fe: 0.085 |
Al: 1.02 Fe: 0.255 |
Al: 0.999974 Fe: 0.999940 |
Al: 26 Fe: 26 |
Al: 88.5 Fe: 92.3 |
date |
Chosen wavelength [nm] |
LOD |
LOQ |
correlation coefficient |
Sum of quality assurance samples |
Recovery of quality assurance samples [%] |
October 20, 2017; measurement of mass balance samples – filters and test vessels pH 6 and 8 |
Al: 394.401* Fe: 260.709* Ti: 307.866* |
Al: 2.16 Fe: 0.300 Ti: 0.149 |
Al: 6.48 Fe: 0.900 Ti: 0.448 |
Al: 0.999942 Fe: 0.999965 Ti: 0.999923 |
Al: 21 Fe: 21 Ti: 21 |
Al: 81.0 Fe: 95.5 Ti: 100 |
Method validation summary (ICP-MS)
Limits of detection (LODs), limits of quantification (LOQs) and correlation coefficients (r)
Limits of detection (LOD) within all measurement series: 0.041 μg Ti / L.
Limits of quantification (LOQ) within all measurement series: 0.123 μg Ti / L.
Correlation coefficients (r) within all measurement series: > 0.9997
Recovery of fortified samples (n = 4): 106 -110 %
Mean recovery of certified reference material TMDA-52.4 (lot no. 0615, Environment Canada): 102% (n=5)
Data source
Materials and methods
Results and discussion
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.