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EC number: 215-686-9 | CAS number: 1344-08-7
- 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
- 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:
- 11 February 2010 - 22 February 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
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
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Sodium sulfide (Na2(Sx))
- EC Number:
- 215-686-9
- EC Name:
- Sodium sulfide (Na2(Sx))
- Cas Number:
- 1344-08-7
- Molecular formula:
- Na2Sx (x=1.5 - 5)
- IUPAC Name:
- disodium sulfanediide
- Details on test material:
- Identification Sodium polysulfide solution
Chemical Name Sodium polysulfide
Molecular formula Na2Sx (x=2.48)
Molecular weight 125.498
CAS Number 1344-08-7
Description Reddish brown liquid
Batch 707-1
Purity TO BE ADDED!!
Test substance storage In refrigerator (2-8°C) in the dark under nitrogen
Stability under storage conditions Stable
Expiry date 03 June 2010
Constituent 1
Method
- Target gene:
- - S. typhimurium: Histidine gene
- E. coli: Tryptophan gene
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:
- Rat liver S9-mix induced by a combination of phenobarbital and ß-naphthoflavone
- Test concentrations with justification for top dose:
- Experiment 1:
Preliminary test (without and with S9) TA100 and WP2uvrA: 3, 10, 33, 100, 333, 1000, 3330 and 5000 µg/plate.
Main study (without and with S9) TA1535, TA1537 and TA98: 3, 10, 33, 100, 333, 1000, 3330 and 5000 µg/plate.
Experiment 2:
Main study (without and with S9): 33, 100, 333, 1000, 3330, 5000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Milli-Q water
- Justification for choice of solvent/vehicle: the test substance is 25% sodium polysulfide in water
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- without S9
Migrated to IUCLID6: 650 µg/plate in DMSO for TA100
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- without S9
Migrated to IUCLID6: 10 µg/plate in DMSO for TA98
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without S9
Migrated to IUCLID6: 5 µg/plate in saline for TA1535
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without S9
Migrated to IUCLID6: 60 µg/plate in milli-Q water for TA1537
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- without S9
Migrated to IUCLID6: 10 µg/plate in DMSO for WP2uvrA
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene in DMSO for all tester strains
- Remarks:
- with S9
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 hour
NUMBER OF REPLICATIONS:
- Doses of the test substance were tested in triplicate in each strain. Two independent experiments were conducted.
NUMBER OF CELLS EVALUATED: 10E8 per plate
DETERMINATION OF CYTOTOXICITY
- Method: The reduction of the bacterial background lawn, the increase in the size of the microcolonies and the reduction of the revertant colonies
OTHER EXAMINATIONS:
- The presence of precipitation of the test compound on the plates was observed.
- Evaluation criteria:
- A test substance is considered negative (not mutagenic) in the test if:
a) The total number of revertants in tester strain TA100 is not greater than two (2) times the concurrent control, and the total number of revertants in tester strains TA1535, TA1537, TA98 or WP2uvrA is not greater than three (3) times the concurrent control.
b) The negative response should be reproducible in at least one independently repeated experiment.
A test substance is considered positive if:
a) A two-fold (TA100) or more or a three-fold (TA1535, TA1537, TA98, WP2uvrA) or more increase above solvent control in the mean number of revertant colonies is observed in the test substance group.
b) The increase in the mean number of revertant colonies follows the concentration of test substance (dose-response relationship).
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No precipitation was observed up to and including the top of 5000 µg/plate
RANGE-FINDING/SCREENING STUDIES:
- See below.
COMPARISON WITH HISTORICAL CONTROL DATA:
- The negative and strain-specific positive control values were within our laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly.
Any other information on results incl. tables
Toxicity:
Table 1
Reduction of the bacterial background lawn and in the number of revertant colonies
Strain |
Without S9-mix |
With S9-mix |
|
Dose Bacterial Revertant (μg/plate) background lawn colonies |
Dose Bacterial Revertant (µg/plate) background lawn colonies |
||
TA1535 |
1000 slight -1 3330 moderate -1 5000 extreme microcolonies |
3330 extreme microcolonies 5000 extreme microcolonies |
|
TA1537 |
3330 extreme microcolonies 5000 extreme microcolonies |
1000 slight -1 3330 extreme microcolonies 5000 extreme microcolonies |
|
TA98 |
3330 extreme microcolonies 5000 extreme microcolonies |
5000 -2 -1 |
|
-1 No reduction in the number of revertant colonies
-2 No reduction of the bacterial background lawn
Table 2.
Reduction of the bacterial background lawn and in the number of revertant colonies
Strain |
Without S9-mix |
With S9-mix |
|
Dose Bacterial Revertant (μg/plate) background lawn colonies |
Dose Bacterial Revertant (µg/plate) background lawn colonies |
||
TA1535 |
5000 slight -1 |
3330 extreme microcolonies 5000 extreme microcolonies |
|
TA1537 |
3330 extreme microcolonies 5000 extreme microcolonies |
3330 moderate -1 5000 extreme microcolonies |
|
TA98 |
5000 moderate -1to to extreme microcolonies |
5000 -2 -1 |
|
TA100 |
1000 moderate moderate 3330 extreme microcolonies 5000 extreme microcolonies |
1000 moderate -1 3330 extreme microcolonies 5000 extreme microcolonies |
|
-1 No reduction in the number of revertant colonies
-2 No reduction of the bacterial background lawn
Experiment 1: Mutagenic response of Sodium polysulfide solution in theSalmonella typhimuriumreverse mutation assay and in theEscherichia colireverse mutation assay
Mean number of revertant colonies/3 replicate plates (± S.D.) with different strains ofSalmonella typhimuriumand oneEscherichia colistrain |
|||||
Without S9-mixDose (µg/plate) |
TA1535 |
TA1537 |
TA98 |
TA100 |
WP2uvrA |
positive control |
785 ± 42 |
284 ± 34 |
946 ± 60 |
883 ± 5 |
1086 ± 53 |
solvent control |
9 ± 1 |
5 ± 3 |
21 ± 2 |
124 ± 12 |
13 ± 2 |
3 |
|
|
|
115 ± 16 |
20 ± 4 |
10 |
|
|
|
113 ± 7 |
21 ± 4 |
33 |
11 ± 3 |
6 ± 3 |
17 ± 3 |
109 ± 4 |
18 ± 3 |
100 |
8 ± 1 |
5 ± 2 |
21 ± 5 |
116 ± 4 |
20 ± 3 |
333 |
6 ± 2 |
5 ± 1 |
26 ± 1 |
128 ± 13 |
20 ± 3 |
1000 |
5 ± 5 s |
7 ± 3 |
29 ± 7 |
141 ± 7 s |
18 ± 2 |
3330 |
8 ± 2 m |
MC e |
MC e |
154 ± 13 m |
29 ± 5 |
5000 |
MC e |
MC e |
MC e |
135 ± 15 m |
46 ± 9 |
With S9-mix1 |
|
|
|
|
|
positive control |
229 ± 7 |
383 ± 30 |
1026 ± 47 |
1404 ± 11 |
360 ± 5 |
solvent control |
5 ± 2 |
3 ± 1 |
25 ± 2 |
110 ± 3 |
16 ± 2 |
3 |
|
|
|
114 ± 18 |
15 ± 5 |
10 |
|
|
|
112 ± 13 |
16 ± 4 |
33 |
7 ± 1 |
3 ± 1 |
24 ± 4 |
106 ± 12 |
17 ± 3 |
100 |
6 ± 2 |
3 ± 2 |
24 ± 4 |
110 ± 12 |
18 ± 2 |
333 |
6 ± 2 |
4 ± 2 |
27 ± 4 |
105 ± 6 |
14 ± 3 |
1000 |
7 ± 1 |
7 ± 1 s |
35 ± 4 |
148 ± 15 s |
18 ± 3 |
3330 |
MC e |
MC e |
40 ± 4 |
141 ± 9 m |
35 ± 8 |
5000 |
MC e |
MC e |
39 ± 14 |
120 ± 1 m |
53 ± 3 |
Solvent control: 0.1 mlMilli-Q water
1 The S9-mix contained 5% (v/v) S9 fraction
s Bacterial background lawn slightly reduced
m Bacterial background lawn moderately reduced
e Bacterial background lawn extremely reduced
MC Microcolonies
Experiment 2: Mutagenic response of Sodium polysulfide solution in theSalmonella typhimuriumreverse mutation assay and in theEscherichia colireverse mutation assay
Mean number of revertant colonies/3 replicate plates (± S.D.) with different strains ofSalmonella typhimuriumand oneEscherichia colistrain |
|||||
Without S9-mixDose (µg/plate) |
TA1535 |
TA1537 |
TA98 |
TA100 |
WP2uvrA |
positive control |
807 ± 40 |
490 ± 34 |
1081 ± 84 |
1063 ± 27 |
1216 ± 19 |
solvent control |
10 ± 4 |
3 ± 1 |
20 ± 2 |
108 ± 7 |
17 ± 3 |
33 |
9 ± 5 |
3 ± 1 |
25 ± 2 |
110 ± 10 |
18 ± 4 |
100 |
11 ± 6 |
5 ± 2 |
23 ± 2 |
117 ± 15 |
17 ± 3 |
333 |
8 ± 2 |
5 ± 2 |
23 ± 8 |
127 ± 14 |
14 ± 4 |
1000 |
7 ± 1 |
6 ± 1 |
31 ± 3 |
61 ± 23 m |
26 ± 2 |
3330 |
11 ± 5 |
MC e |
30 ± 6 |
MC e |
31 ± 5 |
5000 |
9 ± 3 s |
MC e |
(2) |
MC e |
54 ± 4 |
With S9-mix1 |
|
|
|
|
|
positive control |
167 ± 14 |
312 ± 65 |
685 ± 16 |
1280 ± 30 |
277 ± 8 |
solvent control |
7 ± 3 |
4 ± 1 |
27 ± 4 |
61 ± 5 |
16 ± 2 |
33 |
7 ± 2 |
3 ± 0 |
27 ± 2 |
64 ± 9 |
14 ± 5 |
100 |
3 ± 0 |
3 ± 1 |
25 ± 6 |
61 ± 10 |
14 ± 3 |
333 |
5 ± 2 |
4 ± 2 |
30 ± 3 |
61 ± 5 |
19 ± 4 |
1000 |
11 ± 3 |
4 ± 1 |
50 ± 6 |
73 ± 2 m |
23 ± 5 |
3330 |
MC e |
5 ± 3 m |
58 ± 5 |
MC e |
41 ± 6 |
5000 |
MC e |
MC e |
52 ± 6 |
MC e |
62 ± 7 |
Solvent control: 0.1 ml Milli-Q water
1 The S9-mix contained 10% (v/v) S9 fraction
2 Two plates with 26 and 13 colonies showed a moderately reducedbacterial background lawn and one plate showed an extreme thinning of the microcolony lawn and an increase in the size of the microcolonies
s Bacterial background lawn slightly reduced
m Bacterial background lawn moderately reduced
e Bacterial background lawn extremely reduced
MC Microcolonies
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive
The negative and strain-specific positive control values were within the laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly.
In the absence of S9-mix, Sodium polysulfide solution induced dose related increases in tester strain WP2uvrA in two independently repeated experiments. The increases observed were above the laboratory historical control data range and 3.5 and 3.2-fold the concurrent control.
In the presence of S9-mix, Sodium polysulfide solution induced dose related increases in the tester strains TA98 and WP2uvrA. The increases observed in tester strain WP2uvrA were in two independently repeated experiments, were above the laboratory historical control data range and 3.3 and 3.9-fold the concurrent control. Although the increase observed in tester strain
TA98 was above the laboratory historical control data range, the increase was not three times the concurrent control (2.1-fold) and in the second experiment only. Therefore, this increase is considered to be not biologically relevant and Sodium polysulfide solution is considered to be only mutagenic in the Escherichia coli strain WP2uvrA.
All other bacterial strains showed negative responses over the entire dose range, i.e. no significant dose-related increase in the number of revertants in two independently repeated experiments.
Based on the results of this study it is concluded that Sodium polysulfide solution is not mutagenic in the Salmonella typhimurium reverse mutation assay and that Sodium polysulfide solution is mutagenic in the Escherichia coli reverse mutation assay. - Executive summary:
Evaluation of the mutagenic activity of Sodium polysulfide solution in theSalmonella typhimurium reverse mutation assay and theEscherichia colireverse mutation assay (with independent repeat).
Sodium polysulfide solution was tested in theSalmonella typhimurium reverse mutation assay with four histidine-requiring strains ofSalmonella typhimurium (TA1535, TA1537, TA98 and TA100) and in theEscherichia coli reverse mutation assay with a tryptophan-requiring strain of Escherichia coli (WP2uvrA). The test was performed in two independent experiments in the presence and absence of S9-mix (rat liver S9-mix induced by a combination of phenobarbital and ß-naphthoflavone).
The study procedures described in this report were based on the most recent OECD and EC guidelines.
Batch 707-1 of Sodium polysulfide solution was a reddish brown liquid. The test substance was dissolved in Milli-Q water.
In the dose range finding test, Sodium polysulfide solution was tested up to concentrations of 5000 µg/plate in the absence and presence of S9-mix in the strains TA100 and WP2uvrA. Sodium polysulfide solution did not precipitate on the plates at this dose level. In tester strain TA100, toxicity was observed at dose levels of 1000 μg/plate and above in the absence and presence of S9-mix. In tester strain WP2uvrA, no toxicity was observed at any of the dose levels tested. Results of this dose range finding test were reported as part of the first experiment of the mutation assay.
Based on the results of the dose range finding test, Sodium polysulfide solution was tested in the first mutation assay at a concentration range of 33 to 5000 µg/plate in the absence and presence of 5% (v/v) S9-mix in tester strains TA1535, TA1537 and TA98. Toxicity was observed in all three tester strains, except in tester strain TA98 in the presence of S9-mix.
In an independent repeat of the assay with additional parameters, Sodium polysulfide solution was tested at the same concentration range as the first assay in the absence and presence of 10% (v/v) S9-mix in tester strains TA1535, TA1537, TA98, TA100 and WP2uvrA. Toxicity was observed in all tester strains, except in the tester strains TA98 in the presence of S9-mix and WP2uvrA in the absence and presence of S9-mix.
The negative and strain-specific positive control values were within the laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly.
In the absence of S9-mix, Sodium polysulfide solution induced dose related increases in tester strain WP2uvrA in two independently repeated experiments. The increases observed were abovethelaboratory historical control data range and 3.5 and 3.2-fold the concurrent control.
In the presence of S9-mix, Sodium polysulfide solution induced dose related increases in the tester strains TA98 and WP2uvrA. The increases observed in tester strain WP2uvrA were in two independently repeated experiments, were abovethelaboratory historical control data range and 3.3 and 3.9-fold the concurrent control. Although the increase observed in tester strain TA98 was abovethelaboratory historical control data range, the increase was not three times the concurrent control (2.1-fold) and in the second experiment only. Therefore, this increase is considered to be not biologically relevant and Sodium polysulfide solution is considered to be only mutagenic in theEscherichia colistrain WP2uvrA.
All other bacterial strains showed negative responses over the entire dose range, i.e. no significant dose-related increase in the number of revertants in two independently repeated experiments.
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