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EC number: 937-221-5 | 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 cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02-APR-2013 to 16-DEC-2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted in compliance with GLP and according to the OECD guideline 473.
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 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- yes
- Remarks:
- (see below)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- Version / remarks:
- cited as Directive 84/449/EEC, B.10
- Deviations:
- yes
- Remarks:
- (see below)
- Principles of method if other than guideline:
- Deviations:
Due to a technical error, only one culture was available for the dose-level of 1250 μg/mL in the second experiment with S9 mix. - GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- reaction mass of neodymium carbonate and praseodymium carbonate
- Molecular formula:
- (Nd,Pr)2 (CO3)3
- IUPAC Name:
- reaction mass of neodymium carbonate and praseodymium carbonate
- Reference substance name:
- 937-221-5
- IUPAC Name:
- 937-221-5
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Constituent 2
Method
Species / strain
- Species / strain / cell type:
- primary culture, other: human lymphocytes
- Details on mammalian cell type (if applicable):
- Cultures of human lymphocytes were prepared from whole blood samples obtained from healthy, non-smoking donors and collected into heparinized sterile tubes.
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 fraction (Moltox, Molecular Toxicology, INC, Boone, USA), obtained from the liver of rats treated with Aroclor 1254 (500 mg/kg) by intraperitoneal route, was used as the metabolic activation system.
- Test concentrations with justification for top dose:
- Nominal concentrations corrected to take into account the water content (i.e. correction factor = 1.58)
Experiment 1: 0, 39.06, 78.13, 156.3, 312.5, 625, 1250, 2500, and 5000 µg/mL with or without metabolic activation
Experiment 2: 0, 78.13, 156.3, 312.5, 625, 1250, and 2500 µg/mL with or without metabolic activation - Vehicle / solvent:
- - Vehicle used: Water (batch Nos. 2F2843, 3F0043, 3F0282)
- Justification for choice of solvent/vehicle: A homogenous suspension of the test item was obtained at the concentration of 100 mg/mL in water (after 20-min ultrasonication).
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- (MMC) without metabolic activation: at 2 and 3 µg/mL for the 3-h treatment and at 0.3 and 0.5 µg/mL for the continuous treatment
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- (CPA) with metabolic activation: at 12.5 and 25 µg/mL
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: In suspension
DURATION (see table 1 below for details)
- Exposure duration: 3, 20, or 44 h
- Expression time: 0, 14, or 38 h
- "Selection" time: 3 h before harvesting
- Fixation time: 20, or 44 h
SPINDLE INHIBITOR: Colcemid
STAIN: Giemsa
NUMBER OF REPLICATIONS: Two
NUMBER OF CELLS EVALUATED: 1000 cells per culture for cytotoxicity evaluation; 200 metaphases/dose-level for cytogenetic analysis
DETERMINATION OF CYTOTOXICITY
- Method: Mitotic index [MI] (number of cells in mitosis/number of cells examined)
OTHER:
- Scoring method: The following structural aberrations were recorded for each metaphase: gaps, chromatid and chromosome breaks and exchanges, and others (multiple aberrations and pulverizations). In addition, the following numerical aberrations were recorded when encountered: polyploidy, endoreduplication and hyperdiploidy. - Evaluation criteria:
- ACCEPTANCE CRITERIA
The study was considered valid if all the following criteria were met:
- the frequency of cells with structural chromosome aberration in the vehicle controls was consistent with (but not necessary within) the historical data. In any case, this frequency should be ≤ 5%,
- the frequency of cells with structural chromosome aberration in the positive controls was statistically higher than that of the vehicle controls (p ≤ 0.05) and consistent with (but not necessary within) the historical data.
EVALUATION CRITERIA
- Evaluation of a positive response: a test item was considered positive for inducing chromosomal aberrations if a reproducible and statistically significant increase in the frequency of cells with structural chromosome aberration was observed at one or more dose levels and at one or two harvest times.
- Evaluation of a negative response: a test item was considered negative for inducing chromosomal aberrations if no significant increase was observed in the number of cells with chromosomal aberrations for any of the dose levels and at any harvest times. - Statistics:
- For each experiment and for each harvest time, the frequency of cells with structural chromosome aberration (excluding gaps) in treated cultures was compared to that of the vehicle control cultures. This comparison was performed using the χ² test unless treated culture data were lower than or equal to the vehicle control data. P = 0.05 was be used as the lowest level of significance.
Results and discussion
Test results
- Species / strain:
- primary culture, other: human lymphocytes
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- see in "any other information on results incl. tables" below for details
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- see in "any other information on results incl. tables" below for details
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
- DETAILED RESULTS:
Table 1: Cytotoxicity data
Doses(1) µg/mL |
Mean MI as % of the control |
Decrease in MI (%) |
||||||
- S9 |
+ S9 |
- S9 |
+ S9 |
|||||
Experiment 1 0 |
3-h expo/17-h recov 100 |
3-h expo/17-h recov 100 |
3-h expo/17-h recov - |
3-h expo/17-h recov - |
||||
39.06 |
102 |
88 |
none |
12 |
||||
78.13 |
94 |
82 |
6 |
18 |
||||
156.3 |
107 |
87 |
none |
13 |
||||
312.5 |
98 |
88 |
2 |
12 |
||||
625 |
73 |
88 |
27 |
12 |
||||
1250 |
74 |
76 |
26 |
24 |
||||
2500 P |
- |
- |
- |
- |
||||
5000 P |
- |
73 |
- |
27 |
||||
MMC 2 µg/mL |
35 |
|
65 |
|
||||
MMC 3 µg/mL |
19 |
|
81 |
|
||||
CPA 12.5 µg/mL |
|
34 |
|
66 |
||||
CPA 25 µg/mL |
|
21 |
|
79 |
||||
Experiment 2
0 |
20-h expo
100 |
44-h expo
100 |
3-h expo/ 17-h recov 100 |
3-h expo/ 41-h recov 100 |
20-h expo
- |
44-h expo
- |
3-h expo/ 17-h recov - |
3-h expo/ 41-h recov - |
78.13 |
88 |
120 |
87 |
129 |
12 |
none |
13 |
none |
156.3 |
89 |
105 |
78 |
109 |
11 |
none |
22 |
none |
312.5 |
61 |
107 |
66 |
101 |
39 |
none |
34 |
none |
625 P |
80 |
86 |
63 |
80 |
20 |
14 |
37 |
20 |
1250 P |
86 |
- |
89 |
- |
14 |
- |
11 |
- |
2500 P |
59 |
- |
76 |
- |
41 |
- |
24 |
|
MMC 0.3 µg/mL |
29 |
|
|
|
71 |
|
|
|
MMC 0.5 µg/mL |
31 |
|
|
|
69 |
|
|
|
CPA 12.5 µg/mL |
|
|
28 |
|
|
|
72 |
|
CPA 25 µg/mL |
|
|
30 |
|
|
|
70 |
|
(1): expressed as active item
CPA: cyclophosphamide
expo: exposure
MI: mitotic index
MMC: mitomycin C
P: precipitate observed in the culture medium at the end of treatment
recov: recovery
Table 2: Genotoxicity data
Doses(1) µg/mL |
Cells with structural chromosome aberrations |
|||||||
Frequency (%) including gaps |
Frequency (%) excluding gaps |
|||||||
- S9 |
+ S9 |
- S9 |
+ S9 |
|||||
Experiment 1 0 |
3-h expo/17-h recov 0.0 |
3-h expo/17-h recov 0.0 |
3-h expo/17-h recov 0.0 |
3-h expo/17-h recov 0.0 |
||||
39.06 |
|
|
|
|
||||
78.13 |
|
|
|
|
||||
156.3 |
|
|
|
|
||||
312.5 |
0.0 |
0.0 |
0.0 |
0.0 |
||||
625 |
1.5 |
0.5 |
1.0 |
0.0 |
||||
1250 |
0.5 |
0.0 |
0.5 |
0.0 |
||||
2500 P |
|
|
|
|
||||
5000 P |
|
|
|
|
||||
MMC 2 µg/mL |
|
|
|
|
||||
MMC 3 µg/mL |
41.0 |
|
40.0*** |
|
||||
CPA 12.5 µg/mL |
|
22.0 |
|
21.0*** |
||||
CPA 25 µg/mL |
|
|
|
|
||||
Experiment 2
0 |
20-h expo
0.5 |
44-h expo
1.0 |
3-h expo/ 17-h recov 0.0 |
3-h expo/ 41-h recov 1.5 |
20-h expo
0.5 |
44-h expo
1.0 |
3-h expo/ 17-h recov 0.0 |
3-h expo/ 41-h recov 1.0 |
78.13 |
|
|
|
|
|
|
|
|
156.3 |
1.0 |
|
2.0 |
|
1.0 |
|
2.0 |
|
312.5 |
1.0 |
|
2.5 |
|
1.0 |
|
2.5 |
|
625 P |
2.5 |
2.5 |
3.0 |
0.0 |
1.5 |
2.5 |
3.0* |
0.0 |
1250 P |
|
|
|
|
|
|
|
|
2500 P |
|
|
|
|
|
|
|
|
MMC 0.3 µg/mL |
23.0 |
|
|
|
23.0*** |
|
|
|
MMC 0.5 µg/mL |
|
|
|
|
|
|
|
|
CPA 12.5 µg/mL |
|
|
18.0 |
|
|
|
17.0*** |
|
CPA 25 µg/mL |
|
|
|
|
|
|
|
|
(1): expressed as active item
CPA: cyclophosphamide
expo: exposure
MI: mitotic index
MMC: mitomycin C
P: precipitate observed in the culture medium at the end of treatment
recov: recovery
Statistical analysis: χ² test
***: p < 0.001 (performed only for cells with structural aberrations excluding gaps)
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
Under the experimental conditions of this study, the test item, Reaction mass of neodymium carbonate and praseodymium carbonate, did not induce chromosome aberrations in cultured human lymphocytes, either in the presence or absence of a rat liver metabolizing system. - Executive summary:
The objective of this study was to evaluate the potential of the test item, reaction mass of neodymium carbonate and praseodymium carbonate, to induce chromosome aberrations in cultured human lymphocytes according to the OECD guideline 473 and in compliance with GLP.
The test item, suspended in water for injections, was tested at concentrations up to 5000 µg/mL (act. ingr.) in two independent experiments, both with and without a liver metabolizing system (S9 mix), obtained from rats previously treated with Aroclor 1254. Lymphocyte cultures were exposed to the test or control items for 3 hours (with S9 mix) and 3, 20, or 44 hours (without S9 mix) then rinsed. Following exposure to the test or control items with S9 mix, the cultures were incubated in fresh medium at +37°C until harvest. Harvest times were 20 and 44 hours after the beginning of treatment, corresponding to approximately 1.5 normal cell cycles and 24 hours later, respectively.
The cytotoxicity was indicated by the reduction of mitotic index (MI). Three hours before harvest, each culture was treated with a Colcemid® solution (10 µg/mL) to block cells at the metaphase-stage of mitosis. After hypotonic treatment (KCl 0.075 M), the cells were fixed in a methanol/acetic acid mixture (3/1; v/v), spread on glass slides and stained with Giemsa. All the slides were coded for scoring.
The frequencies of cells with structural chromosome aberrations of the vehicle and positive controls were as specified in acceptance criteria. The study was therefore considered to be valid.
Regarding the first experiment, the dose-levels selected for the treatment were 39.06, 78.13, 156.3, 312.5, 625, 1250, 2500 and 5000 µg/mL, both with and without S9 mix. A precipitate was observed in the culture medium at the end of the treatment period, at dose levels ≥ 2500 µg/mL. Moreover, following the 3-hour treatment and the 20-hour harvest time, a slight cytotoxicity was observed at dose-levels ≥ 625 µg/mL without S9 mix (26-27%) and at 5000 µg/mL with S9 mix (27%). However, no significant increase in the frequency of cells with structural chromosomal aberrations was noted after the 3-hour treatment with or without S9 mix.
In the second experiment, the dose-levels selected were 78.13, 156.3, 312.5, 625, 1250 and 2500 µg/mL both with and without S9 mix. A precipitate was observed in the culture medium at the end of the treatment periods, at dose levels ≥ 625 µg/mL. Further, a moderate cytotoxicity was noted at 312.5 and 2500 µg/mL (39 and 41%, respectively) following the 20-hour treatment without S9 mix. In the presence of S9 mix, a slight cytotoxicity was noted at 312.5 and 625 µg/mL (34 and 37%, respectively), at the 20-hour harvest time only. Nevertheless, no significant increase in the frequency of cells with structural chromosomal aberrations was noted after the 3-, 20- and 44-hour treatments, except for a statistically significant increase at 625 µg/mL (3.0% vs. 0.0% for the vehicle control) following the 20-hour treatment with S9 mix. However, this increase remained within the vehicle control historical range (0.0 to 4.5%) and no similar effect was observed in both experiments. Thus the slight increase observed in the second experiment was not considered to be biologically relevant.
In conclusion, these results were considered to meet the criteria of a negative response in both experiments. Consequently, under the experimental conditions of this study, the test item, reaction mass of neodymium carbonate and praseodymium carbonate, did not induce chromosome aberrations in cultured human lymphocytes, either in the presence or absence of a rat liver metabolizing system.
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