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EC number: 222-328-5 | CAS number: 3426-45-7
- 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
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- Auto flammability
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- Additional physico-chemical properties of nanomaterials
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- Endpoint summary
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- 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
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- Additional ecotoxological information
- Toxicological Summary
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- Acute Toxicity
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- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
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- Additional toxicological data
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Genetic toxicity in vitro
In vitro mutagenicity in bacteria
A single reliable (Klimisch 1) key study is available ( Balázs Orovecz, 2017), performed according to OECD guideline 471 and in agreement with GLP requirements. In this study, Lutetium oxalate did not show mutagenic activity in the applied bacterium tester strains in the absence or presence of metabolic activation under the conditions of the test system.
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:
- From 10 March 2017 to 13 July 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP compliance
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 22 September 2015
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- Correction factor: 1.16
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor-supplemented post-mitochondrial fraction (S9 fraction) obtained from the liver of male Wistar rats treated with with phenobarbital and B-naphthoflavone at 80 mg/kg/ day by oral gavage for three consecutive days.
- Test concentrations with justification for top dose:
- - Preliminary concentration range finding test (Informatory toxicity test): Based on the available information and the solubility and compatibility test, 100 mg/mL stock solution was prepared in DMSO, which was diluted in 6 steps by factors of 2, 2.5 and approximately √10. The revertant colony numbers and the inhibition of the background lawn of auxotrophic cells of two of the tester strains (Salmonella typhimurium TA98, TA100) were determined at the concentrations of 5000, 2500, 1000, 316, 100, 31.6 and 10 μg/plate of the test item.
- Test item concentrations in the Mutagenicity tests (Initial Mutation test and Confirmatory Mutation test): Based on the results of the preliminary tests, 100 mg/mL stock solution was prepared in DMSO, which was diluted by serial dilutions in several steps to obtain the dosing formulations for lower doses. The maximum test concentration was 5000 μg test item/plate.
Examined concentrations in the Initial Mutation Test were 5000, 1581, 500, 158.1, 50 and 15.81 μg/plate and examined concentrations in the Confirmatory Mutation Test were 5000, 1581, 500, 158.1, 50, 15.81 and 5 μg/plate. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO and distilled water
- Justification for choice of solvent/vehicle: The solubility of the test item was examined using Distilled water, N,N-Dimethylformamide (DMF) and Dimethyl sulfoxide (DMSO). At 100 mg/mL concentration suspension with quick sedimentation was observed in each case. After approximately 4 minutes incubation in an ultrasonic water bath no changes were observed using Distilled water and DMF, however white suspension with slower sedimentation was observed using DMSO. Therefore DMSO was selected as vehicle (solvent) for the study. The obtained stock formulation (50 μL) with the solution of top agar and phosphate buffer was examined in a test tube without test bacterium suspension to examine the formulation compatibility (Preliminary Compatibility Test). - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- other:
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-1,2-phenylenediamine [1] and 2-aminoanthracene [2]
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation for Preliminary Concentration Range Finding Test and Initial Mutation Test); preincubation (Confirmatory Mutation test)
DURATION
- Preincubation period: 20 minutes at 37°C
- Exposure duration: 48 hours
- Incubation: 37°C
NUMBER OF REPLICATIONS: 3
NUMBER OF CELLS EVALUATED: all revertants per plates are counted manually.
OTHER EXAMINATIONS:
- Other: Visual examination of the plates was performed : precipitation or signs of growth inhibition were recorded and reported. - Rationale for test conditions:
- Concentrations were selected on the basis of the Preliminary Compatibility Test and Preliminary Concentration Range Finding Test (Informatory Toxicity Test). In the Initial Mutation Test and Confirmatory Mutation Test different concentrations were used.
- Evaluation criteria:
- CRITERIA FOR VALIDITY:
The study was considered valid if:
- the number of revertant colonies of the negative (solvent) and positive controls were in the historical control range in all strains of the main tests;
- at least five analyzable concentrations were presented in all strains of the main tests.
CRITERIA FOR A POSITIVE RESPONSE:
A test item was considered mutagenic if:
- a dose–related increase in the number of revertants occurred and/or;
- a reproducible biologically relevant positive response for at least one of the dose groups occurred in at least one strain with or without metabolic activation.
An increase was considered biologically relevant if:
- the number of reversion was more than two times higher than the reversion rate of the negative (solvent) control in Salmonella typhimurium TA98, TA100 and Escherichia coli WP2 uvrA bacterial strains;
- the number of reversions was more than three times higher than the reversion rate of the negative (solvent) control in Salmonella typhimurium TA1535 and TA1537 bacterial strains.
CRITERIA FOR A NEGATIVE RESPONSE:
The test item was considered to have shown no mutagenic activity in this study if it produces neither a dose-related increase in the number of revertants nor a reproducible biologically relevant positive response at any of the dose groups, with or without metabolic activation. - Statistics:
- No statistical analysis was performed.
- Key result
- Species / strain:
- other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- In the Initial Mutation Test (using the plate incorporation method), the highest revertant rate was observed in Salmonella typhimurium TA1535 bacterial strain at 15.81 μg/plate concentration with metabolic activation (the observed mutation factor value was 1.79). There was no dose-response relationship, the observed mutation factor values were below the biologically relevant threshold limit and the numbers of revertant colonies were within the historical control range.
In the Confirmatory Mutation Test (pre-incubation method), the highest revertant rate was observed in Salmonella typhimurium TA1535 bacterial strain at 5000 μg/plate concentration with metabolic activation (the observed mutation factor value was 1.30).
There was no dose-response relationship, the observed mutation factor values were below the biologically relevant threshold limit and the numbers of revertant colonies were within the historical control range.
Higher numbers of revertant colonies compared to the vehicle (solvent) control were detected in the main tests in some other sporadic cases. However, no dose-dependence was observed in those cases and they were below the biologically relevant threshold value. The numbers of revertant colonies were within the historical control range in each case, so they were considered as reflecting the biological variability of the test.
Sporadically, lower revertant counts compared to the vehicle (solvent) control were observed in the main tests at some non-cytotoxic concentrations. However, no background inhibition was recorded and the mean numbers of revertant colonies were in the historical control range in all cases, thus they were considered as biological variability of the test system.
Inhibitory, cytotoxic effect of the test item was not detected in the Initial Mutation Test and Confirmatory Mutation Test.
Precipitate/slight precipitate was detected on the plates at 5000 and 1581 μg/plate concentrations in the main tests in all examined strains with and without metabolic activation. - Conclusions:
- The reported data of this mutagenicity assay show that under the experimental conditions applied the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.
In conclusion, the test item tris[oxalate(2-)]dilutetium (Batch Number: 1534498) had no mutagenic activity in the applied bacterium tester strains under the test conditions used in this study. - Executive summary:
The test item tris[oxalate(2-)]dilutetium was tested for potential mutagenic activity using the Bacterial Reverse Mutation Assay.
The experiments were carried out using histidine-requiring auxotroph strains of Salmonella typhimurium (Salmonella typhimurium TA98, TA100, TA1535 and TA1537) and the tryptophan-requiring auxotroph strain of Escherichia coli
(Escherichia coli WP2 uvrA) in the presence and absence of a post mitochondrial supernatant (S9 fraction) prepared from the livers of phenobarbital/β-naphthoflavone induced rats.
The study included a Preliminary Compatibility Test, a Preliminary Concentration Range Finding Test (Informatory Toxicity Test), an Initial Mutation Test (Plate Incorporation Method) and a Confirmatory Mutation Test (Pre-Incubation Method).
Based on the results of a solubility test, the test item was formulated in DMSO. Concentrations of 5000, 2500, 1000, 316, 100, 31.6 and 10 μg/plate were examined in the Preliminary Concentration Range Finding Test. Based on the results of the Range Finding Test, the test item concentrations in the Initial Mutation Test were 5000, 1581, 500, 158.1, 50 and 15.81 μg/plate, and in the Confirmatory Mutation Test were 5000, 1581, 500, 158.1, 50, 15.81 and 5 μg/plate.
In the Initial Mutation Test and Confirmatory Mutation Test, none of the observed revertant colony numbers were above the respective biological threshold value. There were no dose-related trends and no indication of any treatment effect. In all test item treated groups, the numbers of revertant colonies did not exceed the biological relevance when compared to the vehicle control and were within the normal biological variability of the test system.
Precipitate/slight precipitate was detected on the plates in the main tests in all examined strains with and without metabolic activation at higher concentrations.
Inhibitory, cytotoxic effect of the test item was not detected in the Initial Mutation Test and Confirmatory Mutation Tests.
The mean values of revertant colonies of the negative (vehicle/solvent) control plates were within the historical control range, the reference mutagens showed the expected increase in the number of revertant colonies, the viability of the bacterial cells was checked by a plating experiment in each test. At least five analyzable concentrations were presented in all strains of the main tests, the examined concentration range was considered to be adequate. The study was considered to be valid.
The reported data of this mutagenicity assay show that under the experimental conditions applied the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.
In conclusion, the test item tris[oxalate(2-)]dilutetium (Batch Number: 1534498) had no mutagenic activity in the applied bacterium tester strains under the test conditions used in this study.
Reference
Table 1:
Concentration (µg/plate) |
Mean values of revertants / Mutation factor (MF) |
Salmonella typhimuriumtester strains |
Escherichia coli |
||||||||
TA98 |
TA100 |
TA1535 |
TA1537 |
WP2 uvrA |
|||||||
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
||
Untreated control |
Mean |
20.7 |
26.3 |
88.0 |
92.3 |
11.0 |
12.0 |
12.3 |
14.3 |
49.3 |
52.0 |
MF |
1.02 |
0.89 |
1.04 |
1.00 |
0.94 |
1.29 |
1.00 |
0.88 |
1.07 |
1.20 |
|
DMSO control |
Mean |
20.3 |
29.7 |
84.3 |
92.0 |
11.7 |
9.3 |
12.3 |
16.3 |
46.0 |
43.3 |
MF |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
|
Distilled water control |
Mean |
-- |
-- |
91.3 |
-- |
14.7 |
-- |
-- |
-- |
49.3 |
-- |
MF |
-- |
-- |
1.08 |
-- |
1.26 |
-- |
-- |
-- |
1.07 |
-- |
|
5000 |
Mean |
20.3 P |
24.3 P |
85.7 P |
97.0 P |
16.3 P |
13.7 P |
13.7 P |
13.7 P |
40.0 P |
50.0 P |
MF |
1.00 |
0.82 |
1.02 |
1.05 |
1.40 |
1.46 |
1.11 |
0.84 |
0.87 |
1.15 |
|
1581 |
Mean |
22.7 SP |
30.7 SP |
96.0 SP |
95.0 SP |
16.0 SP |
14.3 SP |
16.0 SP |
17.3 SP |
50.7 SP |
50.7 SP |
MF |
1.11 |
1.03 |
1.14 |
1.03 |
1.37 |
1.54 |
1.30 |
1.06 |
1.10 |
1.17 |
|
500 |
Mean |
21.7 |
33.0 |
103.3 |
98.0 |
16.0 |
16.0 |
14.7 |
14.7 |
44.7 |
48.3 |
MF |
1.07 |
1.11 |
1.23 |
1.07 |
1.37 |
1.71 |
1.19 |
0.90 |
0.97 |
1.12 |
|
158.1 |
Mean |
19.3 |
23.3 |
100.3 |
94.3 |
17.0 |
15.7 |
14.3 |
15.0 |
44.0 |
47.0 |
MF |
0.95 |
0.79 |
1.19 |
1.03 |
1.46 |
1.68 |
1.16 |
0.92 |
0.96 |
1.08 |
|
50 |
Mean |
21.3 |
28.3 |
102.7 |
99.7 |
17.3 |
15.0 |
16.0 |
16.3 |
36.3 |
45.3 |
MF |
1.05 |
0.96 |
1.22 |
1.08 |
1.49 |
1.61 |
1.30 |
1.00 |
0.79 |
1.05 |
|
15.81 |
Mean |
21.7 |
23.0 |
94.3 |
95.3 |
17.3 |
16.7 |
14.3 |
13.3 |
36.0 |
47.0 |
MF |
1.07 |
0.78 |
1.12 |
1.04 |
1.49 |
1.79 |
1.16 |
0.82 |
0.78 |
1.08 |
|
NDP (4 µg) |
Mean |
373.3 |
|
|
|
|
|
|
|
|
|
MF |
18.36 |
|
|
|
|
|
|
|
|
|
|
2AA (2 µg) |
Mean |
|
2440.0 |
|
2396.0 |
|
202.3 |
|
202.3 |
|
|
MF |
|
82.25 |
|
26.04 |
|
21.68 |
|
12.39 |
|
|
|
2AA (50 µg) |
Mean |
|
|
|
|
|
|
|
|
|
264.7 |
MF |
|
|
|
|
|
|
|
|
|
6.11 |
|
SAZ (2 µg) |
Mean |
|
|
1193.3 |
|
1198.7 |
|
|
|
|
|
MF |
|
|
13.07 |
|
81.73 |
|
|
|
|
|
|
9AA (50 µg) |
Mean |
|
|
|
|
|
|
400.7 |
|
|
|
MF |
|
|
|
|
|
|
32.49 |
|
|
|
|
MMS (2 µL) |
Mean |
|
|
|
|
|
|
|
|
959.3 |
|
MF |
|
|
|
|
|
|
|
|
19.45 |
|
P: Precipitate
SP: Slight precipitate
Table 2:
Concentration (µg/plate) |
Mean values of revertants / Mutation factor (MF) |
Salmonella typhimuriumtester strains |
Escherichia coli |
||||||||
TA98 |
TA100 |
TA1535 |
TA1537 |
WP2 uvrA |
|||||||
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
||
Untreated control |
Mean |
20.3 |
20.7 |
99.0 |
99.3 |
11.0 |
10.3 |
10.0 |
12.7 |
39.0 |
44.0 |
MF |
0.97 |
1.02 |
1.11 |
1.03 |
0.89 |
1.03 |
0.86 |
1.19 |
1.06 |
1.09 |
|
DMSO control |
Mean |
21.0 |
20.3 |
89.3 |
96.0 |
12.3 |
10.0 |
11.7 |
10.7 |
36.7 |
40.3 |
MF |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
|
Distilled water control |
Mean |
-- |
-- |
95.0 |
-- |
11.0 |
-- |
-- |
-- |
39.3 |
-- |
MF |
-- |
-- |
1.06 |
-- |
0.89 |
-- |
-- |
-- |
1.07 |
-- |
|
5000 |
Mean |
19.0 P |
21.7 P |
58.0 P |
61.7 P |
11.0 P |
13.0 P |
9.3 P |
11.3 P |
43.3 P |
44.0 P |
MF |
0.90 |
1.07 |
0.65 |
0.64 |
0.98 |
1.30 |
0.80 |
1.06 |
1.18 |
1.09 |
|
1581 |
Mean |
18.3 P |
22.7 P |
77.7 P |
81.0 P |
12.3 P |
11.7 P |
9.7 P |
8.3 P |
39.3 P |
43.0 P |
MF |
0.87 |
1.11 |
0.87 |
0.84 |
1.00 |
1.17 |
0.83 |
0.78 |
1.07 |
1.07 |
|
500 |
Mean |
20.0 |
21.3 |
87.0 |
78.0 |
12.0 |
9.7 |
9.0 |
11.0 |
38.0 |
44.3 |
MF |
0.95 |
1.05 |
0.97 |
0.81 |
0.97 |
0.97 |
0.77 |
1.03 |
1.04 |
1.10 |
|
158.1 |
Mean |
19.0 |
21.3 |
93.7 |
88.3 |
13.0 |
10.0 |
10.0 |
12.3 |
37.7 |
44.3 |
MF |
0.90 |
1.05 |
1.05 |
0.92 |
1.05 |
1.00 |
0.86 |
1.16 |
1.03 |
1.10 |
|
50 |
Mean |
16.3 |
24.3 |
86.7 |
89.7 |
11.7 |
10.7 |
8.0 |
10.3 |
41.7 |
42.0 |
MF |
0.78 |
1.20 |
0.97 |
0.93 |
0.95 |
1.07 |
0.69 |
0.97 |
1.14 |
1.04 |
|
15.81 |
Mean |
20.3 |
22.0 |
86.0 |
86.7 |
10.7 |
10.3 |
9.0 |
12.0 |
39.0 |
44.0 |
MF |
0.97 |
1.08 |
0.96 |
0.90 |
0.86 |
1.03 |
0.77 |
1.13 |
1.06 |
1.09 |
|
5 |
Mean |
16.7 |
22.0 |
87.3 |
90.0 |
12.7 |
11.0 |
8.0 |
11.0 |
40.3 |
42.07 |
MF |
0.79 |
1.08 |
0.98 |
0.94 |
1.03 |
1.10 |
0.69 |
1.03 |
1.10 |
1.06 |
|
NDP (4 µg) |
Mean |
404.0 |
|
|
|
|
|
|
|
|
|
MF |
19.24 |
|
|
|
|
|
|
|
|
|
|
2AA (2 µg) |
Mean |
|
2390.0 |
|
2394.7 |
|
210.0 |
|
201.3 |
|
|
MF |
|
117.54 |
|
24.94 |
|
21.00 |
|
18.88 |
|
|
|
2AA (50 µg) |
Mean |
|
|
|
|
|
|
|
|
|
216.7 |
MF |
|
|
|
|
|
|
|
|
|
5.37 |
|
SAZ (2 µg) |
Mean |
|
|
1175.3 |
|
1210.0 |
|
|
|
|
|
MF |
|
|
12.37 |
|
110.00 |
|
|
|
|
|
|
9AA (50 µg) |
Mean |
|
|
|
|
|
|
392.2 |
|
|
|
MF |
|
|
|
|
|
|
33.60 |
|
|
|
|
MMS (2 µL) |
Mean |
|
|
|
|
|
|
|
|
988.0 |
|
MF |
|
|
|
|
|
|
|
|
25.12 |
|
P: Precipitate
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Mode of Action Analysis / Human Relevance Framework
Genetic toxicity in vitro
In vitro mutagenicity in bacteria
Lutetium oxalate was tested for potential mutagenic activity using the Bacterial Reverse Mutation Assay (Balázs Orovecz, 2017) according to OECD guideline 471 and in agreement with GLP requirements. The experiments were carried out using histidine-requiring auxotrophic strains of Salmonella typhimurium (TA98, TA100, TA1535 and TA1537) and the tryptophan-requiring auxotrophic strain of E. coli (WP2uvrA) in the presence and absence of metabolic activation (cofactor-supplemented post-mitochondrial S9 fraction (rat liver)) prepared from the livers of phenobarbital/beta-naphthoflavone-induced rats. The study included a preliminary compatibility test, a preliminary concentration range finding test, an initial mutation test and a confirmatory mutation test. Based on the results of a solubility test, the Lutetium oxalate was formulated in DMSO. Based on the results of the range finding test, the test item concentrations in the initial mutation test and in the confirmatory mutation test (5 strains) were 5000, 1581, 500, 158.1, 50, 15.81 and 5 μg/plate. The tests were considered to be valid. The data demonstrate that the test item had no mutagenic activity in the applied bacterium tester strains in the absence or presence of metabolic activation under the test conditions used in this study. Untreated, negative (solvent) and positive controls were run concurrently. The results obtained in the control treatments were all within the historical control range. This study was considered reliable (Klimisch 1) and was considered as the key study for endpoint coverage.
Additional information
Justification for classification or non-classification
Based on the available information, Lutetium oxalate is considered not to be mutagenic and is not classified according to the CLP regulation.
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