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EC number: 235-101-0 | CAS number: 12068-53-0
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- 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)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht, Mainz, Germany
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Dialuminium zinc tetraoxide
- EC Number:
- 235-101-0
- EC Name:
- Dialuminium zinc tetraoxide
- Cas Number:
- 12068-53-0
- Molecular formula:
- ZnAl2xO(3x+1), x = 1 – 9
- IUPAC Name:
- dialuminum; zinc(2+); oxygen(2-)
- Test material form:
- solid - liquid: suspension
- Details on test material:
- - Name of test material (as cited in study report): D-PrisM
- Physical state: pale, yellowish powder
- Analytical purity: 100%
- Composition of test material: zinc aluminate
- Lot/batch No.: PC080519/1
- Expiration date of the lot/batch: June 2018
- Stability under test conditions: stable at room temperature
- Storage condition of test material: in a closed vessel at room temperature protected from humidity
Constituent 1
Method
- Target gene:
- his operon
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA 97a, TA 98, TA 100, TA 102 and TA 1535
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with Aroclor 1254 (500 mg/kg bw)
- Test concentrations with justification for top dose:
- First experiment: 55, 150, 499, 1508 and 5005 µg/plate with and without metabolic activation
Second experiment: 324, 625, 1247, 2527 and 5003 µg/plate with and without metabolic activation - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water and DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-Nitro-1,2-phenylene diamine (20 µg in DMSO, -S9, TA 97a, TA 98 and TA 102); sodium azide (1 µg in water; -S9; TA 100 and TA 1535); 2-Amino-anthracene (1 µg in DMSO, +S9; TA 97a, TA 100, TA 102 and TA 1535); Benzo-a-pyrene (20 µg in DMSO; + S9, TA 98)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
First experiment: in agar (plate incorporation)
Second experiment: pre-incubation
DURATION
- Preincubation period: 20 min (second experiment)
- Exposure duration: 48 h (first and second experiment)
NUMBER OF REPLICATIONS: 4 replications each in 2 independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: other: Cytotoxicity was evaluated at test concentrations of 5007 and 1504 µg/plate. Per tester strain, 4 plates were exposed for 48 h in a plate incorporation test. The quotient of the number of revertant colonies in the titre plates divided by the toxicity test plates was evaluated to determine cytoxicity. If the quotient is below 2, the test item is considered as non-cytotoxic. - Evaluation criteria:
- A test item is considered to have mutagenic potential, if a significant, reproducible increase of revertant colonies per plate (increase factor ≥ 2) in at least one strain is observed. A concentration-related increase over the range tested is also taken as a sign of mutagenicity.
Validity criteria
Negative control plates must demonstrate the characteristic mean number of spontaneous revertants compared to historical control data. - Statistics:
- Mean values and standard errors were calculated from the examined parameters.
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA 97a, TA 98, TA 100, TA 102 and TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- ADDITIONAL INFORMATION ON CYTOTOXICITY:
Cytotoxicity was tested at 5007 µg/plate and 1504 µg/plate with 4 plates per strain on maximal soft agar. The quotient titre/tox (number of colonies in medium/number of colonies in test solutions) was calculated below 2 (see table 3). Thus, the test item was considered not to induce cytotoxicity.
Any other information on results incl. tables
Acceptability of the study
Nearly all spontaneous revertants and all positive control values were within the range of historical data. Difference of revertants lying outside the range in the first experiment are marginal. In detail, the mean number of revertants for TA 97a in the water control plates counted 97 ± 3.4 which is slightly below the historical range reaching from 99 - 159 ± 11.
Additionally, the mean number of revertants for TA 100 in DMSO control plates counted 88 ± 4.6 which is slightly below the historical range from 89 - 155 ± 14.Therefore, the study was considered as valid.
Table 1. Experiment 1: Test results for D-PrisM (plate incorporation)
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate ± standard deviation |
||||
Base-pair substitution type |
Frameshift type |
|||||
TA 100 |
TA 1535 |
TA 97a |
TA 98 |
TA 102 |
||
– |
DMSO |
88± 4.6 |
16 ± 1.3 |
108± 2.5 |
10± 2.4 |
171± 8.8 |
– |
H2O |
105± 5.3 |
22 ± 4.1 |
97± 3.4 |
11± 2.7 |
151± 24.4 |
– |
55 |
94± 18 |
15± 3 |
105± 10 |
14± 1 |
131± 27 |
– |
150 |
96± 4 |
16± 2 |
110± 5 |
15± 2 |
125± 19 |
– |
499 |
111± 4 |
17± 3 |
112± 5 |
10± 1 |
127± 22 |
– |
1508 |
94± 15 |
15 ± 2 |
111± 6 |
10± 2 |
133± 17 |
– |
5005 |
104± 7 |
14 ± 2 |
106± 9 |
13± 3 |
140± 8 |
– |
Positive controls |
SA |
SA |
4NPD |
4NPD |
4NPD |
Mean No. of colonies/plate ± SD |
495 ± 60 |
201 ± 18 |
456 ± 18 |
240 ± 19 |
604±99 |
|
+ RLI (4%) |
DMSO |
112± 8.8 |
14± 1.9 |
115± 1.7 |
14± 3.2 |
171± 4.1 |
+ RLI (4%) |
H2O |
128 ± 18.7 |
15 ± 2.1 |
108 ± 8.0 |
13 ± 6.2 |
176 ± 16.8 |
+ RLI(4%) |
55 |
105 ± 15 |
10 ± 3 |
99 ± 6 |
15 ± 4 |
145 ± 17 |
+ RLI(4%) |
150 |
105 ± 10 |
11 ± 2 |
111 ± 5 |
14 ± 2 |
128 ± 10 |
+ RLI(4%) |
499 |
98 ± 8 |
11 ± 1 |
110 ± 5 |
14 ± 4 |
126 ± 23 |
+ RLI(4%) |
1508 |
111 ± 4 |
14 ± 3 |
114 ± 5 |
12 ± 3 |
150 ± 5 |
+ RLI(4%) |
5005 |
98 ± 16 |
16 ± 2 |
108 ± 6 |
12 ± 2 |
132 ± 18 |
+ RLI(4%) |
Positive controls |
2AA |
2AA |
2AA |
BaP |
2AA |
Mean No. of colonies/plate ± SD |
446 ± 63 |
201 ± 11 |
499 ± 22 |
202 ± 13 |
594 ± 88 |
SA = Sodium azide
4NPD = 4-Nitro-o-phenylenediamine
2AA = 2-Amino-anthracene
BaP = Benzo-a-pyrene
SD = standard deviation
RLI = induced male Sprague Dawley rat liver S9
Table 2. Experiment 2: Test results for D-PrisM (preincubation)
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate ± standard deviation |
||||
Base-pair substitution type |
Frameshift type |
|||||
TA 100 |
TA 1535 |
TA 97a |
TA 98 |
TA 102 |
||
– |
DMSO |
92± 5.1 |
12± 1.7 |
102± 4.3 |
15± 1.7 |
147± 8.3 |
– |
H2O |
100 ± 7.5 |
14± 2.9 |
118± 2.2 |
16± 2.8 |
178± 20.3 |
– |
324 |
95± 6 |
13± 2 |
117± 6 |
16± 3 |
168± 17 |
– |
625 |
81± 14 |
14± 2 |
113± 2 |
14± 1 |
180± 24 |
– |
1247 |
76± 11 |
14± 2 |
102± 5 |
13± 1 |
161± 3 |
– |
2527 |
102± 17 |
16± 2 |
116± 3 |
15± 2 |
171± 14 |
– |
5003 |
100± 16 |
16±2 |
114± 4 |
14± 3 |
147± 4 |
– |
Positive controls |
SA |
SA |
4NPD |
4NPD |
4NPD |
Mean No. of colonies/plate ± SD |
513± 38 |
230± 25 |
475± 68 |
221± 15 |
635 ± 51 |
|
+ RLI (4%) |
DMSO |
88 ± 11.8 |
11 ± 2.2 |
110 ± 2.2 |
14 ± 2.9 |
159 ± 8.7 |
+ RLI (4%) |
H2O |
86± 8.5 |
13± 2.2 |
112± 5.5 |
15± 3.9 |
155± 8.7 |
+ RLI(4%) |
324 |
83± 5 |
12± 4 |
110± 7 |
13± 1 |
154± 10 |
+ RLI(4%) |
625 |
79± 5 |
12± 2 |
111± 2 |
14± 1 |
191± 9 |
+ RLI(4%) |
1247 |
89± 17 |
9± 3 |
114± 5 |
13± 3 |
175± 5 |
+ RLI(4%) |
2527 |
91± 11 |
13± 1 |
116± 7 |
13± 3 |
147± 3 |
+ RLI(4%) |
5003 |
86± 6 |
11± 3 |
107± 4 |
13± 3 |
153± 16 |
+ RLI(4%) |
Positive controls |
2AA |
2AA |
2AA |
BaP |
2AA |
Mean No. of colonies/plate ± SD |
472 ± 144 |
217 ± 15 |
554 ± 23 |
242 ± 22 |
612 ± 72 |
SA = Sodium azide
4NPD = 4-Nitro-o-phenylenediamine
2AA = 2-Amino-anthracene
BaP = Benzo-a-pyrene
SD = standard deviation
RLI = induced male Sprague Dawley rat liver S9
Table 3: Toxicity control
Titre values |
TA 97a |
TA 98 |
TA 100 |
TA 102 |
TA 1535 |
||||||
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
||
280± 8 |
316± 8 |
208± 37 |
213± 27 |
238± 11 |
271± 13 |
273± 58 |
220± 14 |
302± 99.0 |
277± 63.6 |
||
Toxicity control |
1504 µg/mL |
274± 17.0 |
267± 49.5 |
258± 5.7 |
275± 7.1 |
317± 35.4 |
276± 49.5 |
277± 52.3 |
336± 19.8 |
275± 4.2 |
247± 21.2 |
5007 µg/mL |
237± 7.1 |
248± 2.8 |
186± 5.7 |
209± 4.2 |
239± 4.2 |
250± 5.7 |
334± 11.3 |
358± 5.7 |
237± 7.1 |
223± 15.6 |
|
Titre/Tox |
1504 µg/mL |
1.02 |
0.59 |
0.81 |
0.39 |
0.75 |
0.51 |
0.99 |
0.33 |
1.10 |
0.56 |
5007 µg/mL |
1.18 |
0.64 |
1.12 |
0.51 |
1.0 |
0.54 |
0.82 |
0.31 |
1.27 |
0.62 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
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