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EC number: 811-367-9 | CAS number: 11073-79-3
- 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
Toxicity to aquatic algae and cyanobacteria
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016-09-16 to 2016-12-05
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Freshwater Alga and Cyanobacteria, Growth Inhibition Test)
- Version / remarks:
- 23 March 2006
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source: H.C. Starck GmbH, Batch No.of test material: 150273V2
- Expiration date of the lot/batch:July 2021
- Purity test date: 98%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature, dry, dark and tightly closed
- Stability under test conditions:Stable
- Solubility and stability of the test substance in the solvent/vehicle: 4 mg/L (according to OECD 105: loading rate of 100 mg/L and stirring for 72 h at 30 °C)
OTHER SPECIFICS: White Powder - Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: NC = 0 mg/L, A=100 mg/L
- Sampling method: At the start of the test (0 h), the test solutions NC and A were sampled before division to the test vessels (each group: 3 samples of 10 mL). After 24 h and 48 h exposure, only the two additional vessels for chemical analyses of NC
and A were sampled (each group: 2 samples of 10 mL). At the end of the test (72 h), one replicate of the test vessels and the two additional vessels from NC and A were sampled (each group: 3 samples of 10 mL).
- Sample storage conditions before analysis: The samples were filtered (0.45 μm syringe filter, Whatman), filled in plastic centrifuge tubes and stored (< 2 weeks) in the fridge (5 °C ± 3 °C). Of each treatment, one of the samples from 0 h, 24 h, 48 h and 72 h was sent to the analytical laboratory (ASG) and analysed. The remaining samples were stored as retain samples in the fridge until finalization of the study. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The stock solution was prepared by adding 55.5 mg test item (including a factor of 1.11 to take into account the dilution caused by addition of the algal inoculum) to 500 mL test medium and shaking for 72 h using an overhead shaker at 22.1-22.8 °C in the dark. Subsequently, the test item solution was allowed to settle for ca. 0.5 h before use in the test as single test item loading rate.
- Controls: The negative control (NC; test medium) was treated in the same way as the test item solution. - Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: Raphidocelis subcapitata (now classified as Pseudokirchneriella subcapitata)
- Strain: No. 61.81 SAG
- Source (laboratory, culture collection): From the Culture Collection of Algae at the University of Goettingen and was cultivated in suspension culture. The strain used for this study has been cultured at Hydrotox GmbH since Mai 2016.
- Age of inoculum (at test initiation): 4 d
- Method of cultivation: Holm-Hansen medium under axenic conditions
ACCLIMATION
- Acclimation period: 4d
- Culturing media and conditions (same as test or not): culturing - Holm-Hansen medium, test - OECD TG 201 medium; other conditions are the same (23.2 - 23.3 °C and 73.2 μE m-² s-1 ± 5.6 % continuous lighting)
- Any deformed or abnormal cells observed: no - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 72 h
- Test temperature:
- The temperature during the exposure was 23.1 - 23.3 °C
- pH:
- The pH was 7.8 - 7.5 in the control and 7.7 - 7.4 in the test item treatment.
- Salinity:
- not applicable
- Nominal and measured concentrations:
- nominal: NC = 0; A = 100 mg/L
measured: NC < LOQ (1µg/L); A < LOQ (1µg/L) - Details on test conditions:
- TEST SYSTEM
- Test vessel: Erlenmeyer glass flasks 100 mL, Schott, Mainz
- Type (delete if not applicable): closed; The test vessels were sealed with cellulose stoppers.
- Fill volume: 50 mL
- Aeration: no
- Initial cells density: 7 × 10^3 cells/mL
- Control end cells density: 4.413 x 10^5 cells/mL
- No. of vessels per concentration (replicates): 6
- No. of vessels per control (replicates):6
GROWTH MEDIUM
- Standard medium used: yes (OECD TG 201 medium)
TEST MEDIUM / WATER PARAMETERS
- Culture medium different from test medium: Holm-Hansen medium
OTHER TEST CONDITIONS
- Sterile test conditions: yes
- Adjustment of pH:no
- Photoperiod:continous lighting
- Light intensity and quality: Mean light intensity was 73.2 μE m-² s-1 ± 5.6 %
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Determination of cell concentrations: Measurement of chlorophyll fluorescence to be converted into cell counts per ml by means of a correlation factor. The correlation factor is based on cell counts with a Coulter Counter and the corresponding fluorescence is measured with a microplate fluorescence reader.
- Chlorophyll measurement: Chlorophyll fluorescence (excitation wavelength of 465 nm, emission wavelength of 670 nm)
TEST CONCENTRATIONS
- Justification for using less concentrations than requested by guideline: A preliminary test without GLP was performed before start of this GLP-study. Nominal loading rates of 45, 90 and 180 mg/L test item were tested and resulted in inhibition of -11.3 to -12.6 % for yield and -2.3 to -2.6 % for growth rate.
- Range finding study: yes, not GLP-conform
- Test concentrations (in range finding test): 45, 90 and 180 mg/L
- Results used to determine the conditions for the definitive study: Yes - Reference substance (positive control):
- no
- Duration:
- 72 h
- Dose descriptor:
- LOELR
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: Yield
- Duration:
- 72 h
- Dose descriptor:
- NOELR
- Effect conc.:
- >= 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: Yield
- Duration:
- 72 h
- Dose descriptor:
- LOELR
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- NOELR
- Effect conc.:
- >= 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Details on results:
- - Exponential growth in the control (for algal test): yes
- Observation of abnormalities (for algal test): no
- Unusual cell shape: no (The morphology of the algal cells in the test loading rates as well as in the control showed no obvious abnormality.)
- Colour differences: not reported
- Flocculation: not reported
- Adherence to test vessels: not reported
- Aggregation of algal cells: not reported
- Any stimulation of growth found in any treatment: no
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no
- Effect concentrations exceeding solubility of substance in test medium: no - Validity criteria fulfilled:
- yes
- Remarks:
- Biomass in the control increased by factor 97.8 (≥ 16). The mean coefficient of variation for section-by-section growth rate in control is 30.1 % (≤ 35 %). The coefficient of variation of average specific growth rate in control replicates is 3.8 % (≤ 7 %)
- Conclusions:
- The test item is no toxic ultures of Raphidocelis subcapitata.
- Executive summary:
In a 72 h growth inhibition test, cultures of Raphidocelis subcapitata (Strain No. 61.81 SAG, now classified as Pseudokirchneriella subcapitata) were exposed to Gadolinium zirconium oxide at nominal loading rates of 0 (control) and 100 mg/L under static conditions in accordance with the OECD Guideline 201 (March 2006) and under GLP. The test design was chosen as limit test, as a pre-test (not GLP conform) with 45, 90 and 180 mg/L nominal concentrations showed no growth inhibition.
Within the limit test, the test item loading rate of 100 mg/L resulted in an inhibition of yield of -1 % (after 72 h) and an inhibition of the growth rate of -1.6 % (after 72 h) which is statistically not a significant difference to the control.
As no effect was observed the LOELR for both, growth rate and yield, must exceed 100 mg/L. The NOELR, for yield and growth rate, exceeds or equals 100 mg/L.
The measured Gd- and Zr-concentrations in the test item treatment were below the limit of quantification (< 1 μg/L).
Based on the results of this study, Gadolinium zirconium oxide would not be classified as toxic to R. subcapitata (now classified as P. subcapitata) in accordance with the classification system of CLP. This toxicity study is classified as acceptable and satisfies the guideline requirement for an aquatic toxicity study to algae.
Results synopsis:
Test organism: Raphidocelis subcapitata (now classified as Pseudokirchneriella subcapitata)
Test type: static
Growth rate:
72 h LOELR: > 100 mg/L
72 h NOELR: >= 100 mg/L
Yield:
72 h LOELR: > 100 mg/L
72 h NOELR: >= 100 mg/L
Endpoint(s) effected: Growth rate and yield
Reference
The inhibition of yield in the test item treatments, in relation to the control, is presented in table 2. Respectively, the inhibition of the specific growth rate in the test item treatments, in relation to the control, is presented in table 3. The algae cell concentrations in the control (NC) and the test item treatment are presented in the following illustration part of this documentation (figure 1). The effect loading rates after 72 h exposure are calculated with the statistical software ToxRat Professional 3.2.1 (see table 4).
Table 2: Inhibition of yield after 24 h, 48 h and 72 h exposure.
Nominal test item loading rate [mg/L] | Inhibition of yield [%] | ||
24 h | 48 h | 72 h | |
NC | -- | -- | -- |
100 | -4.0 | 8.5 | -1.1 |
Table 3: Inhibition of growth rate after 24 h, 48 h and 72 h exposure.
Nominal test item loading rate [mg/L] | Inhibition of growth rate [%] | ||
24 h | 48 h | 72 h | |
NC | -- | -- | -- |
100 | -7.6 | 0.4 | -1.6 |
Table 4: Effect loading rates for yield and growth rate at the end of the Test (72 h).
Lowest/ No Observed Effect Loading Rate | Nominal test item loading rate [mg/L] | |
Yield | Growth rate | |
LOELR | > 100 | > 100 |
NOELR | ≥ 100 | ≥100 |
Description of key information
A limit test in accordance with the OECD Test Guideline 201 (23 March 2006) did neither show a significant inhibition of yield (-1.1 %) nor inhibition of growth (-1.6 %) caused by Gadolinium zirconium oxide on the algae Raphidocelis subcapitata (Strain No. 61.81 SAG, now classified as Pseudokirchneriella subcapitata). The results based on the growth rate are as follows: NOELR ≥ 100 mg/L, LOELR > 100 mg/L. The results on yield are similar: NOELR ≥ 100 mg/L, LOELR > 100 mg/L.
Key value for chemical safety assessment
- EC10 or NOEC for freshwater algae:
- 100 mg/L
Additional information
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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