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EC number: 215-214-1 | CAS number: 1313-97-9
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 May 2007 - 3 August 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Government revised Chemical Substance Law according to Notification No. 700 of the Environmental Agency, No. 1039 of the Ministry of Health and Welfare and No. 1014 of the Ministry of International Trade and Industry, 9th December 1996.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Neodymium oxide
- EC Number:
- 215-214-1
- EC Name:
- Neodymium oxide
- Cas Number:
- 1313-97-9
- Molecular formula:
- Nd2O3
- IUPAC Name:
- dineodymium(3+) trioxidandiide
- Test material form:
- solid: particulate/powder
Constituent 1
Method
- Target gene:
- S. typhimurium: Histidine locus.
E. coli: Tryptophan locus.
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix prepared from rats induced with Aroclor 1254
- Test concentrations with justification for top dose:
- - 156.3, 312.5, 625, 1250 and 2500 µg/plate, for the TA 102 strain in the first experiment and all tester strains in the second experiment, either with or without S9 mix,
- 312.5, 625, 1250, 2500 and 5000 µg/plate, for all tester strains except for the TA 102 in the first experiment, either with or without S9 mix. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The test material was insoluble in most vehicles used for in vitro tests and so was prepared as an homogeneous suspension.
The test item was suspended at the following concentrations:
100 mg/mL for the preliminary test and the first experiment; 50 mg/mL for the second experiment.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- mitomycin C
- other: 2-Anthramine
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: Both experiments were performed according to the direct plate incorporation method except for the second test with S9 mix, which was performed according to the preincubation method.
DURATION
- Preincubation period: 60 minutes, 37 °C
- Exposure duration: 48 - 72 hours
NUMBER OF REPLICATES: three plates/dose-level
POSITIVE CONTROLS
The positive controls were dissolved in dimethylsulfoxide (except for Mitomycin C which was dissolved in distilled water).
Without S9 mix:
-sodium azide (NAN3)
-9-Aminoacridine (9AA)
-2-Nitrofluorene (2NF)
-Mitomycin C (MMC)
-4-Nitroquinoline 1-oxide (4NQO)
With S9 mix:
-2-Anthramine (2AM)
-Benzo(a)pyrene (BaP)
TEST SYSTEM
The day before treatment, cultures were inoculated from frozen permanents: a scrape was taken under sterile conditions and put into approximately 6 mL of nutrient broth. The nutrient broth was then placed under agitation in an incubator at 37 °C for about 14 hours, to produce bacterial suspensions.
Metabolic activation system:
The S9 mix consists of induced enzymatic systems contained in rat liver post-mitochondrial fraction (S9 fraction) and the cofactors necessary for their function. S9 fraction was obtained from the liver of rats treated with Aroclor 1254 (500 mg/kg) by the intraperitoneal route. The S9 fraction was preserved in sterile tubes at -80 °C, until use.
The S9 mix was prepared at +4 °C immediately before use and maintained at this temperature until added to the overlay agar.
The composition of S9 mix was as follows:
Glucose-6-phosphate 5 mM
NADP 4 mM
KCl 33 mM
MgCl2 8 mM
Sodium phosphate buffer pH 7.4 100 mM
S9 fraction, protein concentration: 36.4 mg/mL 10 % (v/v)
water to volume
EXPERIMENTAL DESIGN
Treatment:
The test material was tested in a preliminary test and two mutagenicity experiments.
The direct plate incorporation method was performed as follows: test material solution (0.05 mL), S9 mix when required (0.5 mL) and bacterial suspension (0.1 mL) were mixed with 2 mL of overlay agar (containing traces of the relevant amino acid and biotin and maintained at 45 °C). After rapid homogenisation, the mixture was overlaid onto a Petri plate containing minimum medium.
The preincubation method was performed as follows: test material solution (0.05 mL), S9 mix (0.5 mL) and the bacterial suspension (0.1 mL) were incubated for 60 minutes at 37 °C, under shaking, before adding the overlay agar and pouring onto the surface of a minimum agar plate. After 48 to 72 hours of incubation at 37 °C, revertants were scored with an automatic counter (Cardinal counter, Perceptive Instruments, Suffolk CB9 7 BN, UK). - Evaluation criteria:
- A reproducible 2-fold increase (for the TA 98, TA 100, TA 102 and WP2 uvrA strains) or 3-fold increase (for the TA 1535 and TA 1537 strains) in the number of revertants compared with the vehicle controls, in any strain at any dose-level and/or evidence of a dose-response was considered as a positive result. Reference to historical data, or other considerations of biological relevance were taken into account in the evaluation of the data obtained.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium 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
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- 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
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- 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
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- 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
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- 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
- Species / strain:
- E. coli WP2 uvr A
- 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: A moderate to marked precipitate was observed in the Petri plates when scoring the revertants at dose-levels ≥156.3 µg/plate.
RANGE-FINDING/SCREENING STUDIES:
To assess the toxicity of the test material to the bacteria, six dose-levels (one plate/dose-level) were tested in the TA 98, TA 100, TA 102 and WP2 uvrA strains, with and without S9 mix. The evaluation of the toxicity was performed on the basis of the observation of the decrease in the number of revertant colonies and/or a thinning of the bacterial lawn.
A moderate to strong precipitate was observed in the Petri plates when scoring the revertants at dose-levels ≥ 100 µg/plate. At 5000 µg/plate the strong precipitate sometimes (with the TA 102 strain with and without S9 mix) interfered with scoring making the plates unreadable.
No noteworthy toxicity which could be considered as relevant was noted towards the four strains used, with and without S9 mix.
COMPARISON WITH HISTORICAL CONTROL DATA: The control data reported in these report are in the range of the historical control data observed in the laboratory.
Any other information on results incl. tables
Table 2: First experiment (direct plate incorporation) -Mean revertant colony counts
|
TA 102 |
TA 1535 |
TA 1537 |
||||||
Conc. |
- MA |
+ MA |
Cytotoxic |
- MA |
+ MA |
Cytotoxic |
- MA |
+ MA |
Cytotoxic |
0* |
314 |
459 |
No |
11 |
21 |
No |
8 |
6 |
No |
156.3 |
279 |
413 |
No (Mp) |
- |
- |
- |
- |
- |
- |
312.5 |
340 |
478 |
No (Mp) |
11 |
19 |
No (Mp) |
8 |
7 |
No (Mp) |
625 |
292 |
560 |
No (Mp) |
12 |
18 |
No (Mp) |
4 |
7 |
No (Mp) |
1250 |
234 |
458 |
No (Sp) |
12 |
7 |
No (Mp/Sp) |
3 |
7 |
No (Sp) |
2500 |
64 |
302 |
No (Sp) |
6 |
10 |
No (Sp) |
2 |
4 |
No (Sp) |
5000 |
- |
- |
- |
U |
5 |
No (Sp) |
U |
3 |
No (Sp) |
Positive control |
1540 |
3709 |
No |
491 |
158 |
No |
448 |
85 |
No |
|
TA 98 |
TA 100 |
WP2uvrA |
||||||
Conc. |
- MA |
+ MA |
Cytotoxic |
- MA |
+ MA |
Cytotoxic |
- MA |
+ MA |
Cytotoxic |
0* |
20 |
33 |
No |
151 |
107 |
No |
27 |
41 |
No |
312.5 |
18 |
28 |
No (Mp) |
150 |
92 |
No (Mp) |
34 |
49 |
No (Mp) |
625 |
18 |
19 |
No (Mp) |
207 |
119 |
No (Sp/Mp) |
38 |
41 |
No (Mp) |
1250 |
19 |
22 |
No (Sp) |
215 |
119 |
No (Sp/Mp) |
30 |
38 |
No (Sp) |
2500 |
14 |
29 |
No (Sp) |
271 |
109 |
No (Sp) |
16 |
37 |
No (Sp) |
5000 |
U |
15 |
No (Sp) |
U |
88 |
No (Sp) |
U |
37 |
No (Sp) |
Positive control |
140 |
1090 |
No |
706 |
438 |
No |
1347 |
309 |
No |
*solvent control with DMSO
Mp : Moderate precipitate
Sp : Strong precipitate
U: unreadable
MA : metabolic activation
Table 3: Second experiment (direct plate incorporation without S9 mix and preincubation with S9 mix) -Mean revertant colony counts
|
TA 1535 |
TA 1537 |
TA 98 |
||||||
Conc. |
- MA |
+ MA |
Cytotoxic |
- MA |
+ MA |
Cytotoxic |
- MA |
+ MA |
Cytotoxic |
0* |
15 |
13 |
No |
4 |
7 |
No |
30 |
25 |
No |
156.3 |
14 |
13 |
No (Mp) |
8 |
5 |
No (Mp) |
25 |
23 |
No (Mp) |
312.5 |
12 |
13 |
No (Mp) |
6 |
9 |
No (Mp) |
22 |
20 |
No (Mp) |
625 |
11 |
10 |
No (Mp) |
7 |
7 |
No (Mp) |
23 |
23 |
No (Mp) |
1250 |
15 |
9 |
No (Sp) |
3 |
6 |
No (Sp) |
23 |
15 |
No (Sp) |
2500 |
10 |
4 |
No (Sp) |
2 |
3 |
No (Sp) |
18 |
16 |
No (Sp) |
Positive control |
577 |
184 |
No |
351 |
126 |
No |
192 |
1144 |
No |
|
TA 100 |
TA 102 |
WP2 uvrA |
||||||
Conc. |
- MA |
+ MA |
Cytotoxic |
- MA |
+ MA |
Cytotoxic |
- MA |
+ MA |
Cytotoxic |
0* |
99 |
138 |
No |
393 |
520 |
No |
27 |
24 |
No |
156.3 |
113 |
151 |
No (Mp) |
412 |
426 |
No (Mp) |
29 |
30 |
No (Mp) |
312.5 |
125 |
98 |
No (Mp) |
525 |
419 |
No (Mp) |
27 |
24 |
No (Mp) |
625 |
134 |
143 |
No (Mp) |
521 |
581 |
No (Mp) |
28 |
28 |
No (Mp) |
1250 |
98 |
104 |
No (Sp) |
486 |
562 |
No (Sp) |
27 |
27 |
No (Sp) |
2500 |
65 |
59 |
No (Sp) |
497 |
658 |
No (Sp) |
25 |
24 |
No (Sp) |
Positive control |
594 |
493 |
No |
2953 |
1660 |
No |
806 |
213 |
No |
*solvent control with DMSO
Mp : Moderate precipitate
Sp : Strong precipitate
U: unreadable
MA : metabolic activation
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: Negative
Under the conditions of this study, the test material did not show any mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium and Escherichia coli. - Executive summary:
The potential of the test material to induce reverse gene mutations in Salmonella typhimurium and Escherichia coli was evaluated in a study performed according to the standardised guidelines OECD 471 and EU Method B13/14.
The test material was tested in two independent experiments, with and without a metabolic activation system (S9 mix, prepared from a liver post mitochondrial fraction (S9 fraction) of rats induced with Aroclor 1254).
Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102 and one strain of Escherichia coli, WP2uvrA, were used. Each strain was exposed to 156.3 to 5000 µg/plate of the test material (three plates/dose-level). After 48 to 72 hours of incubation at 37 °C, the revertant colonies were scored. Solvent control (DMSO) and positive controls were used.
The number of revertants for the vehicle and positive controls was as specified in the acceptance criteria. The study was therefore considered valid.
A moderate to marked precipitate was observed in the Petri plates when scoring the revertants at dose-levels ≥ 156.3 µg/plate. No toxicity was noted towards all the strains used either with or without S9 mix. The test item did not induce any noteworthy increase in the number of revertants, either with or without S9 mix, in any of the six strains.
Under the conditions of the study, the test material did not show any mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium and Escherichia coli with and without metabolic activation.
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