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EC number: 939-559-9 | 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 Aug 2012 - 07 Sep 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- (adopted 21 Jul 1997)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- (adopted 30 May 2008)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt fuer Gesundheit und Lebensmittelsicherheit, Erlangen, Germany
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reaction mass of ammonium diaqua[bis(oxalate)]oxoniobate(1-) hydrate and ammonium hydrogen oxalate oxalic acid (1:1:1) dehydrate
- IUPAC Name:
- Reaction mass of ammonium diaqua[bis(oxalate)]oxoniobate(1-) hydrate and ammonium hydrogen oxalate oxalic acid (1:1:1) dehydrate
- Test material form:
- solid
Constituent 1
Method
- Target gene:
- his operon
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- Co-factor supplemented liver S9 homogenate from phenobarbital and ß-naphthoflavone induced male Wistar rats
- Test concentrations with justification for top dose:
- - pre-test (toxicity): 3.16, 10.0, 31.6, 100, 316, 1000, 2500, and 5000 µg/plate
- main test (mutagenicity): 31.6, 100, 316, 1000, 2500, and 5000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-o-phenylene-diamine; 2-aminoanthracene
- Remarks:
- +S9: 2-aminoanthracene 2.5 µg/plate (TA 98, TA 100, TA 1535, TA 1537) 10 µg/plate (TA 102); -S9: 4-nitro-o-phenylene-diamine 10 µg/plate (TA 98) 40 µg/plate (TA 1537), sodium azide 10 µg/plate (TA 100, TA 1535), methylmethanesulfonate 1 µL/plate (TA 102)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
DURATION
- Preincubation period: 60 min
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 3 plates each in 2 independent tests
DETERMINATION OF CYTOTOXICITY
- Method: evaluation of background lawn, reduction in the number of revertants down to a mutation factor ≤0.5 in relation to the solvent control - Evaluation criteria:
- The Mutation Factor is calculated by dividing the mean value of the revertant counts through the mean values of the solvent control.
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, TA 102 the number of reversions is at least twice as high
- if in tester strains TA 1535, TA 1537 the number of reversions is at least three times higher
than the reversion rate of the solvent control.
According to the 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.
A test item producing neither a dose related increase nor a reproducible biologically relevant response at any of the dose groups is considered to be non-mutagenic in this system.
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: no
No further information given in the study report.
RANGE-FINDING/SCREENING STUDIES:
The test item was not toxic to the tester strains TA 98 and TA 100 up to limit concentrations.
COMPARISON WITH HISTORICAL CONTROL DATA:
The results of the positive and solvent controls are within the range of the historical control data.
Any other information on results incl. tables
Tab.1: Experiment 1 (plate incorporation) without metabolic activation - Number of revertants per plate (mean of 3 plates ± standard deviation)
Conc. [µg/plate] |
TA 98 |
Mutation Factor |
TA 100 |
Mutation Factor |
TA 1535 |
Mutation Factor |
TA 1537 |
Mutation Factor |
TA 102 |
Mutation Factor |
Solvent control |
22±5.5 |
1.0 |
98±11.9 |
1.0 |
6±0.6 |
1.0 |
8±2.0 |
1.0 |
211±22.9 |
1.0 |
31.6 |
15±2.5 |
0.7 |
88±7.2 |
0.9 |
9±2.3 |
1.4 |
8±1.7 |
1.0 |
189±7.4 |
0.9 |
100 |
17±5.0 |
0.8 |
92±9.5 |
0.9 |
5±2.6 |
0.8 |
8±2.6 |
1.0 |
184±16.0 |
0.9 |
316 |
20±3.8 |
0.9 |
112±16.5 |
1.1 |
7±0.6 |
1.1 |
9±3.8 |
1.1 |
186±20.0 |
0.9 |
1000 |
23±5.5 |
1.1 |
95±15.2 |
1.0 |
4±1.2 |
0.7 |
8±1.7 |
1.0 |
176±6.7 |
0.8 |
2500 |
16±2.5 |
0.7 |
88±7.8 |
0.9 |
5±0.6 |
0.7 |
7±1.0 |
0.9 |
187±20.3 |
0.9 |
5000 |
20±3.6 |
0.9 |
87±15.1 |
0.9 |
6±4.0 |
1.0 |
5±1.2 |
0.7 |
190±8.7 |
0.9 |
Positive control |
251±17.6 |
11.6 |
642±137.8 |
6.5 |
996±137.1 |
157.2 |
78±10.7 |
9.8 |
2110±84.9 |
10.0 |
Solvent control: A. dest.
Positive controls: 4-nitro-o-phenylene-diamine (TA 98, TA 1537); sodium azide (TA 100, TA 1535); methylmethanesulfonate (TA 102)
Mutation Factor = mean revertants (test item)/mean revertants (solvent control)
Tab. 2: Experiment 1 (plate incorporation) with metabolic activation - Number of revertants per plate (mean of 3 plates ± standard deviation)
Conc. [µg/plate] |
TA 98 |
Mutation Factor |
TA 100 |
Mutation Factor |
TA 1535 |
Mutation Factor |
TA 1537 |
Mutation Factor |
TA 102 |
Mutation Factor |
Solvent control |
34±7.6 |
1.0 |
113±13.5 |
1.0 |
7±2.5 |
1.0 |
8±3.8 |
1.0 |
296±16.1 |
1.0 |
31.6 |
29±6.0 |
0.9 |
130±20.8 |
1.1 |
8±1.2 |
1.0 |
6±4.2 |
0.8 |
278±25.1 |
0.9 |
100 |
26±1.2 |
0.8 |
111±5.9 |
1.0 |
5±2.1 |
0.7 |
7±1.7 |
0.9 |
255±14.8 |
0.9 |
316 |
30±3.0 |
0.9 |
113±4.6 |
1.0 |
9±1.5 |
1.2 |
8±1.0 |
1.0 |
281±18.5 |
0.9 |
1000 |
20±7.2 |
0.6 |
110±2.6 |
1.0 |
6±2.3 |
0.8 |
9±2.3 |
1.2 |
250±28.2 |
0.8 |
2500 |
25±1.7 |
0.7 |
101±6.0 |
0.9 |
8±1.5 |
1.0 |
8±0.6 |
1.1 |
213±8.7 |
0.7 |
5000 |
16±2.5 |
0.5 |
108±4.0 |
1.0 |
10±3.1 |
1.4 |
6±4.6 |
0.7 |
216±20.2 |
0.7 |
Positive control |
2247±270.3 |
66.8 |
1768±89.8 |
15.6 |
56±7.2 |
7.6 |
263±40.9 |
34.4 |
944±42.7 |
3.2 |
Solvent control: A. dest.
Positive controls: 2-aminoanthracene (all tester strains)
Mutation Factor = mean revertants (test item)/mean revertants (solvent control)
Tab. 3: Experiment 2 (preincubation) without metabolic activation - Number of revertants per plate (mean of 3 plates ± standard deviation)
Conc. [µg/plate] |
TA 98 |
Mutation Factor |
TA 100 |
Mutation Factor |
TA 1535 |
Mutation Factor |
TA 1537 |
Mutation Factor |
TA 102 |
Mutation Factor |
Solvent control |
17±1.2 |
1.0 |
84±11.6 |
1.0 |
6±3.1 |
1.0 |
8±3.5 |
1.0 |
171±13.5 |
1.0 |
31.6 |
23±3.8 |
1.3 |
104±5.7 |
1.2 |
9±1.7 |
1.6 |
9±2.6 |
1.1 |
183±21.6 |
1.1 |
100 |
23±3.0 |
1.3 |
82±5.0 |
1.0 |
6±3.1 |
1.1 |
9±1.0 |
1.1 |
188±10.5 |
1.1 |
316 |
21±4.7 |
1.2 |
87±9.5 |
1.0 |
9±1.5 |
1.5 |
8±4.6 |
1.0 |
162±16.1 |
0.9 |
1000 |
22±8.4 |
1.3 |
81±4.0 |
1.0 |
6±1.5 |
1.1 |
10±3.6 |
1.2 |
163±19.6 |
1.0 |
2500 |
18±7.8 |
1.1 |
71±9.7 |
0.8 |
7±0.6 |
1.3 |
7±4.9 |
1.1 |
184±6.8 |
1.1 |
5000 |
22±4.0 |
1.3 |
73±20.0 |
0.9 |
7±0.0 |
1.2 |
6±3.2 |
0.7 |
180±20.1 |
1.1 |
Positive control |
390±33.5 |
22.5 |
1256±99.0 |
15.0 |
932±74.1 |
164.4 |
103±14.3 |
12.4 |
1811±82.9 |
10.6 |
Solvent control: A. dest.
Positive controls: 4-nitro-o-phenylene-diamine (TA 98, TA 1537); sodium azide (TA 100, TA 1535); methylmethanesulfonate (TA 102)
Mutation Factor = mean revertants (test item)/mean revertants (solvent control)
Tab. 4: Experiment 2 (preincubation) with metabolic activation - Number of revertants per plate (mean of 3 plates ± standard deviation)
Conc. [µg/plate] |
TA 98 |
Mutation Factor |
TA 100 |
Mutation Factor |
TA 1535 |
Mutation Factor |
TA 1537 |
Mutation Factor |
TA 102 |
Mutation Factor |
Solvent control |
37±10.1 |
1.0 |
104±7.8 |
1.0 |
6±1.2 |
1.0 |
9±0.6 |
1.0 |
256±30.9 |
1.0 |
31.6 |
42±7.5 |
1.1 |
101±16.6 |
1.0 |
11±2.1 |
1.8 |
9۬.3 |
1.1 |
277±25.5 |
1.1 |
100 |
41±13.1 |
1.1 |
84±8.5 |
0.8 |
9±2.1 |
1.5 |
9±3.8 |
1.1 |
277±11.2 |
1.1 |
316 |
31±6.7 |
0.9 |
102±20.5 |
1.0 |
7±1.5 |
1.2 |
8±4.4 |
0.9 |
270±19.5 |
1.1 |
1000 |
38±11.4 |
1.0 |
101±8.1 |
1.0 |
7±2.6 |
1.1 |
8±4.0 |
0.9 |
262±15.8 |
1.0 |
2500 |
30±9.3 |
0.8 |
86±13.7 |
0.8 |
7±2.5 |
1.1 |
6±5.9 |
0.7 |
225±1.7 |
0.9 |
5000 |
27±2.1 |
0.7 |
78±4.6 |
0.8 |
7±3.6 |
1.1 |
8±2.5 |
1.0 |
227±16.2 |
0.9 |
Positive control |
2095±255.2 |
79.2 |
1933±303.9 |
18.6 |
81±18.1 |
12.8 |
190±40.9 |
21.9 |
612±102.0 |
2.4 |
Solvent control: A. dest.
Positive controls: 2-aminoanthracene (all tester strains)
Mutation Factor = mean revertants (test item)/mean revertants (solvent control)
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
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