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EC number: 915-048-6 | 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:
- weight of evidence
- Study period:
- From 20 May 1994 to 5 September 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
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: U.S.A./E.P.A./T.S.C.A. Federal Register, Vol. 50, No. 188, Subpart F, 27th September 1985
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Dicerium trisulphide
- EC Number:
- 234-603-7
- EC Name:
- Dicerium trisulphide
- Cas Number:
- 12014-93-6
- Molecular formula:
- Ce2S3
- IUPAC Name:
- Dicerium trisulphide
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): Sulfure de cerium
Constituent 1
Method
- Target gene:
- Each strain derived from Salmonella typhimurium LT2 contains one mutation in the histidine operon, resulting in a requirement for histidine. The strain of Escherichia coli contains one mutation in the tryptophan operon, resulting in a requirement for tryptophan. In addition, to increase their sensitivity to mutagenic substances, additional mutations have been added:
- the rfa mutation causes partial loss of the lipopolysaccharide barrier that coats the surface of the bacteria and increases permeability to large molecules that do not penetrate the normal bacteira cell wall,
- the uvr (uvrB for S. typhimurium and uvrA for E; coli) mutation is a deletion of a gene code for the DNA excision repair system, which renders the bacteria unable to use this repair mechanism to remove the damaged DNA,
- the addition of the pKM 101 ampicillin resistant plasmidic R-factor in the strains TA98 and TA100 enhances their detection sensitivity to some mutagens.
The TA1535, TA100 and WP2uvrA strains are reverted by base-pair substitution mutagens and the TA1537 and TA98 by frameshift mutagens.
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- post-mitochondrial fraction (S9 fraction) obtained from a liver microsomal fraction of rats induced with Aroclor 1254 (500 mg/kg) by the intraperitoneal route.
- Test concentrations with justification for top dose:
- 0, 62.5, 125, 250, 500 and 1000 µg/plate for all mutagenicity experiments with and without S9 mix
The top dose was selected according to the results of the preliminary toxicity test and to the following criteria:
- for non-toxic, freely soluble test substances, the top dose is 5000 µg/plate, according to international regualtions,
- for non-toxic, poorly soluble test substances, the top dose is the lowest precipitating dose,
- for toxic test substances, irrespective of solubility, the top dose is based on the level of toxicity: moderately to markedly sparse bacterial lawn and/or decrease by approximately 50% of the number of revertants when compared to the controls. However, precipitation should not interface with the scoring of the test. - Vehicle / solvent:
- Vehicle: distilled water
Controls
- Untreated negative controls:
- yes
- Remarks:
- without metabolic activation only
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- N-ethyl-N-nitro-N-nitrosoguanidine
- other: 2-anthramine
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: The preliminary experiment, the both experiments without S9 mix and the first experiment with S9 mix were performed according to the direct plate incorporation method. The second experiment with S9 mix was performed according to the preincubation method.
DURATION
- Preincubation period: The test substance solution, the S9 mix (0.5 mL) and the strain (0.1 mL) were incubated for 60 min at 37ºC before adding the overlay agar and pouring onto the surface of a minimum agar plate.
- Exposure duration: 48 to 72 hours
- Incubation: 37°C
- Expression time (cells in growth medium): the number of revertant colonies is determined at the end of the exposure time.
NUMBER OF REPLICATIONS: 3
NUMBER OF CELLS EVALUATED: all revertants per plates are counted
ACCEPTANCE CRITERIA: This study was considered valid because the following criteria were fully met:
- the number of revertants of the controls was within the range of historical data,
- the number of revertants of the positive controls was higher than that of the controls and was within the range of our historical data. - Evaluation criteria:
- The following criteria were used as an aid for determining a positive response:
- a reproducible and significant dose relationship,
and/or
- a reproducible and significant increase (i.e. a doubling in the number of revertants for at least one of the tested strains when compared to that of the controls) for at least one of the doses.
A test substance is considered as non-mutagenic in this test system if the above two criteria are not fully met. - Statistics:
- Biological and statistical significances were considered during the evaluation.
No further information is available.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- 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:
- S. typhimurium TA 1537
- 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:
- S. typhimurium TA 98
- 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:
- S. typhimurium 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:
- The control results were equivalent to those usually obtained in CIT laboratory. The number of revertants induced by the positive controls was higher than the controls, indicating the sensitivity of the test system.
Due to the poor solubility of the test substance, all tested doses precipitated.
The test substance did not induce any significant increase in the number of revertants, with or without S9 mix, in any of the 5 strains.
Any other information on results incl. tables
Table 1: Summary table of the first experiment
With (+) or without (-) S9 mix |
Test substance concentration (µg/plate) |
Number of revertants (number of colonies/plate) |
|||||||||||||||||||
Base-pair substitution type |
Frameshift type |
||||||||||||||||||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
|||||||||||||||||
S9 mix (-) |
SR |
88 |
93 |
74 |
85 |
8 |
9 |
9 |
9 |
29 |
23 |
17 |
23 |
38 |
23 |
21 |
27 |
11 |
9 |
12 |
11 |
0 |
91 |
65 |
75 |
77 |
8 |
14 |
6 |
9 |
31 |
19 |
22 |
24 |
30 |
26 |
25 |
27 |
11 |
5 |
10 |
9 |
|
62.5 |
103 |
98 |
103 |
3+ |
12 |
11 |
17 |
13+ |
19 |
23 |
25 |
22+ |
27 |
25 |
16 |
23+ |
13 |
5 |
11 |
10+ |
|
125 |
90 |
84 |
95 |
6+ |
8 |
10 |
10 |
9+ |
21 |
18 |
21 |
20+ |
25 |
21 |
28 |
25+ |
10 |
12 |
5 |
9+ |
|
250 |
106 |
88 |
92 |
9+ |
13 |
8 |
13 |
11+ |
23 |
21 |
26 |
23+ |
27 |
25 |
29 |
27+ |
5 |
11 |
10 |
9+ |
|
500 |
103 |
93 |
95 |
5++ |
20 |
14 |
10 |
15++ |
24 |
24 |
26 |
24++ |
25 |
29 |
26 |
27++ |
12 |
8 |
8 |
9++ |
|
1000* |
104 |
105 |
116 |
7++ |
18 |
10 |
13 |
14++ |
22 |
24 |
17 |
21++ |
20 |
31 |
30 |
27++ |
9 |
10 |
7 |
9++ |
|
S9 mix (+) |
0 |
110 |
101 |
92 |
101 |
11 |
14 |
12 |
12 |
35 |
36 |
19 |
30 |
25 |
25 |
27 |
26 |
8 |
11 |
6 |
8 |
62.5 |
105 |
89 |
97 |
97+ |
16 |
9 |
12 |
12+ |
21 |
35 |
27 |
28+ |
15 |
24 |
23 |
21+ |
8 |
10 |
11 |
10+ |
|
125 |
96 |
101 |
110 |
102+ |
18 |
20 |
11 |
16+ |
30 |
30 |
20 |
27+ |
25 |
16 |
28 |
23+ |
9 |
6 |
12 |
9+ |
|
250 |
106 |
89 |
96 |
97+ |
11 |
11 |
13 |
12+ |
17 |
17 |
32 |
22+ |
23 |
22 |
29 |
25+ |
9 |
8 |
7 |
8+ |
|
500 |
109 |
91 |
95 |
98++ |
10 |
10 |
18 |
13++ |
32 |
31 |
35 |
33++ |
22 |
29 |
34 |
28++ |
5 |
10 |
9 |
8++ |
|
1000* |
93 |
89 |
93 |
92++ |
19 |
12 |
17 |
16++ |
22 |
30 |
34 |
29++ |
34 |
21 |
29 |
28++ |
10 |
8 |
11 |
10++ |
|
Positive control not requiring S9 mix |
Name |
Sodium azide |
Sodium azide |
N-ethyl-N-nitro-nitrosoguanidine |
2-Nitrofluorene |
9-Aminoacridine |
|||||||||||||||
Concentration (µg/plate) |
1 |
1 |
2 |
0.5 |
50 |
||||||||||||||||
Number of colonies/plate |
607 |
467 |
577 |
550 |
459 |
475 |
460 |
465 |
889 |
913 |
824 |
875 |
157 |
123 |
122 |
134 |
135 |
261 |
130 |
175 |
|
Positive control requiring S9 mix |
Name |
2-Anthramine |
2-Anthramine |
2-Anthramine |
2-Anthramine |
2-Anthramine |
|||||||||||||||
Concentration (µg/plate) |
2 |
2 |
10 |
2 |
2 |
||||||||||||||||
Number of colonies/plate |
3406 |
3355 |
3144 |
3302 |
375 |
346 |
349 |
357 |
807 |
827 |
865 |
833 |
2814 |
2972 |
3037 |
2941 |
460 |
596 |
591 |
549 |
SR: Spontaneous reversants: negative control
O: Vehicle control (distilled water)
*: Pink colouration
P: Precipitate
+: slight
++: moderate
Applicant's summary and conclusion
- Conclusions:
- Under these experimental conditions, the test substance Dicerium trisulphide did not show mutagenic activity in the reverse mutation assay on Salmonella typhimurium and Escherichia coli.
- Executive summary:
The objective of this study was to evaluate the potential of the test substance Dicerium trisulphide to induce a reverse mutation in bacteria Salmonella typhimurium and Escherichia coli (Ames test). This test enables the detection of base-pair substitution or frameshift mutagens.
A preliminary toxicity test was performed to define the doses to be used for the mutagenicity study. The test substance was then tested in two independent tests, with or without a metabolic activation system, the S9 mix, prepared from a liver microsomal fraction (S9) of rats induced with Aroclor 1254.
The tests were performed according to the direct plate incorporation method except the second test with S9 mix, according to the preincubation method (1 hour, 37°C).
Four strains of bacteria Salmonella typhimurium: TA1535, TA1537, TA98 and TA100 and one strain of Escherichia coli: WP2uvrA were used. Each strain was exposed to 5 doses of the test substance (3 plates/dose). After 48 to 72 hours of incubation at 37°C, the revertant colonies were scored.
The test substance Cerium sulphide was prepared in distilled water at 10 mg/mL.
The doses of Cerium sulphide were 62.5, 125, 250, 500 and 1000 µg/plate.
Due to the poor solubility of the test substance, all tested doses precipitated.
In both tests, the control results were equivalent to those usually obtained in CIT laboratory. The number of revertants induced by the positive controls was higher than the controls, indicating the sensitivity of the test system.
The test substance Cerium sulphide did not induce any significant increase in the number of revertants, with or without S9 mix, in any of the 5 strains, in both of the 2 tests.
Under these experimental conditions, the test substance Dicerium trisulphide did not show mutagenic activity in the reverse mutation assay on Salmonella typhimurium and Escherichia coli.
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