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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
The mutagenic potential of Gadolinium zirconium oxide was investigated in a bacterial reverse gene mutation assay according to OECD 471 with and without metabolic activation. There was no increase of mutant colonies compared to the negative control observed in all strains tested. Consequently the target substance Gadolinium zirconium oxide is considered to be non-mutagenic.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016-07-26 to 2016-09-19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- Histidine locus
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Details on mammalian cell type (if applicable):
- Source of cells: MOLTOX, INC., NC 28607, USA (TA 98, 1535 and 102), Xenometrix AG, Switzerland (TA 100 and 1537).
Nutrient medium: 8 g Nutrient Broth and 5 g NaCl per litre
Selective Agar: 2% Vogel-Bonner-Glucose-Minimal Agar
Overlay Agar: 7.0 g Agar Agar, 6.0 g NaCl, 10.5 mg L-hisitidne x HCl x H2O, 12.2 mg Biotin per litre - Metabolic activation:
- with and without
- Metabolic activation system:
- Mammalian Microsomal Fraction S9 Mix
- Test concentrations with justification for top dose:
- The test item concentrations to be applied in the main experiments were chosen according to the results of the pre-experiment (Conditions: see "Any other information on materials and methods"; Results: see "Any other information on results" Table 2). Due to strong precipitation 2500 μg/plate was selected as the maximum concentration.
The concentration range covered two logarithmic decades. Two independent experiments were performed with the following concentrations:
Experiment I:
10.0, 31.6, 100, 316, 1000 and 2500 μg/plate
Experiment II:
3.16, 10.0, 31.6, 100, 316, 1000 and 2500 μg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: distilled water
- Justification for choice of solvent/vehicle: The solvent was compatible with the survival of the bacteria and the S9 activity. - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Distilled water
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA 100 and TA 1535, without S9, 10 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Distilled water
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylene-diamine (4-NOPD)
- Remarks:
- TA 98 (10 µg/plate) and TA 1537 (40 µg/plate), without S9
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Distilled water
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- TA 102, 1 µL/plate, without S9
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Distilled water
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene (2-AA)
- Remarks:
- All strains, with S9, 2.5 µg/plate (10 µg/plate for TA 102)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation (experiment I), pre-incubation (experiment II))
- Cell density at seeding (if applicable): approx. 10^9 cells/mL, 100 µL/plate
EXPERIMENTAL PERFORMANCE
- Experiment I :
For the plate incorporation method the following materials were mixed in a test tube and poured over the surface of a minimal agar plate: 100 μL Test solution at each dose level, solvent control, negative control or reference mutagen solution (positive control), 500 μL S9 mix (for testing with metabolic activation) or S9 mix substitution buffer (for testing without metabolic activation), 100 μL Bacteria suspension (cf. Preparation of Bacteria, pre-culture of the strain), 2000 μL Overlay agar.
- Experiment II:
For the pre-incubation method the following materials were mixed and pre-incubated for 60 min at 37 °C: 100 μL of the test item preparation, 100 µL of the tester strain, 500 µL sterile buffer or the metabolic activation system. After adding the overlay agar (2000 μL), the mixture was poured onto the surface of a minimal agar plate.
DURATION
- Preincubation period (Experiment II): 60 min at 37 °C
- Exposure duration: 48 h in the dark at 37 °C
NUMBER OF REPLICATIONS: 3 plates/strain/dose level including the controls
DETERMINATION OF CYTOTOXICITY
Cytotoxicity can be detected by a clearing or rather diminution of the background lawn (indicated as "N" or "B", respectively in the result tables) or a reduction in the number of revertants down to a mutation factor of approximately ≤ 0.5 in relation to the solvent control.
EVALUATION OF MUTAGENICITY
The Mutation Factor is calculated by dividing the mean value of the revertant counts by the mean values of the solvent control (the exact and not the rounded values are used for calculation).
A test item is considered as mutagenic if:
- a clear and dose-related increase in the number of revertants occurs and/or
- a biologically relevant positive response for at least one of the dose groups occurs in at least one tester strain with or without metabolic activation.
A biologically relevant increase is described as follows:
- if in tester strains TA 98, TA 100 and TA 102 the number of reversions is at least twice as high
- if in tester strains TA 1535 and TA 1537 the number of reversions is at least three times higher than the reversion rate of the solvent control - Evaluation criteria:
- A test is considered acceptable if for each strain:
- The bacteria demonstrate their typical responses to ampicillin (TA 98, TA 100, TA 102)
- The negative control plates (A. dest.) with and without S9 mix are within the following ranges (mean values of the spontaneous reversion frequency are
within the historical control data range (2013 -2015) (see “Any other information on material and methods” Table 1)
- Corresponding background growth on negative control, solvent control and test plates is observed
- The positive controls show a distinct enhancement of revertant rates over the control plate
- At least five different concentrations of each tester strain are analysable.
A test item producing neither a dose related increase in the number of revertants nor a reproducible biologically relevant positive response at any of the dose groups is considered to be non-mutagenic in this system. - Statistics:
- According to OECD guidelines, the biological relevance of the results is the criterion for the interpretation of results, a statistical evaluation of the results is not regarded as necessary.
- Species / strain:
- S. typhimurium, other: TA 98, TA 100, TA 1535, TA 1537 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- > 1000 µg/plate without S9 in TA 1535 2500 µg/plate with S9 in TA 98
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium, other: TA 98, TA 100, TA 1535, TA 1537 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- other:
- Remarks:
- Experiment I, precipitation was observed in all tester strains used in the experiment at a concentration of 2500 µg/plate.
- Conclusions:
- Gadolinium zirconium oxide did not cause gene mutations by base pair changes or frameshifts in the genome of the tester strains used. Therefore, Gadolinium zirconium oxide is considered to be non-mutagenic in this bacterial reverse mutation assay.
- Executive summary:
In a reverse gene mutation assay in bacteria, strains TA 98, TA 100, TA 1535, TA 1537 and TA 102 of S. typhimurium were exposed to Gadolinium zirconium oxide (>98 % purity) in water at concentrations of 10.0, 31.6, 100, 316, 1000 and 2500 µg/plate (experiment I) and at concentrations of 3.16, 10.0, 31.6, 100, 316, 1000 and 2500 µg/plate (experiment II) in the presence and absence of mammalian metabolic activation.
Gadolinium zirconium oxide was tested up to the limit concentration (5000 µg/plate) in a pre-experiment. Due to precipitation at the high doses, the maximum dose was reduced to 2500 µg/plate for the main experiment. The positive controls induced the appropriate responses in the corresponding strains. There was no evidence of induced mutant colonies over background in all tester strains in both experiments. Therefore, Gadolinium zirconium oxide is considered to be non-mutagenic in this Salmonella typhimurium reverse mutation assay.
This study is classified as acceptable. This study satisfies the requirement for Test Guideline OPPTS 870.5100; OECD 471 for in vitro mutagenicity (bacterial reverse gene mutation) data.
Reference
Results of the pre-experiment:
Table 2: Results Pre-Experiment
Substance |
Dose (µg/plate) |
TA 98 |
TA 100 |
||
without S9 |
with S9 |
without S9 |
with S9 |
||
Solvent Control (A.dest.) |
|
1.0 |
1.0 |
1.0 |
1.0 |
4-NOPD |
10.0 |
17.7 |
- |
- |
- |
NaN3 |
10.0 |
- |
- |
8.7 |
- |
2-AA |
2.50 |
- |
65.5 |
- |
18.2 |
Test Item |
3.16 |
0.6 |
1.1 |
0.9 |
0.9 |
10.0 |
0.9 |
0.9 |
0.9 |
0.9 |
|
31.6 |
0.7 |
1.1 |
0.9 |
1.0 |
|
100 |
0.8 |
1.0 |
0.9 |
0.9 |
|
316 |
0.8 |
1.0 |
1.0 |
1.0 |
|
1000 |
0.8 |
1.2 |
0.9 |
1.0 |
|
2500 |
0.8 [P] |
0.5 [P] |
0.8 [P] |
1.1 |
|
5000 |
0.7 [P] |
0.5 [P] |
0.8 [P] |
/ [P*] |
* [toxicity parameter]: B = Background lawn reduced, N = No background lawn, P = Precipitation, P* = not evaluable, precipitation interferes with scoring
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
The mutagenic potential of Gadolinium zirconium oxide (target substance) was investigated in a bacterial reverse gene mutation assay according to OECD 471 with and without metabolic activation using five different tester strains of Salmonella typhimurium. There was no increase of mutant colonies compared to the negative control observed in all strains. Consequently, the test item Gadolinium zirconium oxide is considered to be non-mutagenic.
Justification for classification or non-classification
Based on the available data, Gadolinium zirconium oxide does not warrant classification for mutagenicity.
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.