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EC number: 835-272-7 | CAS number: 256374-76-2
- 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:
- key study
- Study period:
- November 22, 2012 to December 3, 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- “OECD Guidelines for the Testing of Chemicals, No. 471, Bacterial Reverse Mutation Test” (Adopted: July 21, 1997)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Version / remarks:
- “Bacterial Reverse Mutation Test” of “Mutagenicity Test” stipulated in the “Test Methods of the New Chemical Substances etc.” (March 31, 2011, Yakushokuhatsu 0331 No. 7, Heisei 23.03.29 Seikyoku No. 5, Kanpokihatsu No. 110331009, partly amended by Yakushokuhatsu 0402 No. 1, Heisei 24.03.28 Seikyoku No. 2, Kanpokihatsu No. 120402001 on April 2, 2012)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Version / remarks:
- “Public Notice stipulating the Standards determined by the Minister of Health, Labour and Welfare based on the provisions in Paragraph 1, Article 57-2 (current: Paragraph 1, Article 57-3) of the Industrial Safety and Health Law” (Public Notice No. 77, the Ministry of Labour, September 1, 1988, amended by Public Notice No. 67, the Ministry of Labour, June 2, 1997 and Public Notice No. 120, the Ministry of Labour, December 25, 2000) and “Specific Test Methods and Test Result Evaluation Methods for Microbial Mutagenicity Test” (Memorandum, Manager of Chemical Substances Investigation Division, Industrial Safety and Health Department, Labour Standards Bureau, the Ministry of Labour, February 8, 1999)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-({2-[(5,5-dimethyl-2-oxo-1,3,2λ⁵-dioxaphosphinan-2-yl)amino]ethyl}amino)-5,5-dimethyl-1,3,2λ⁵-dioxaphosphinan-2-one
- EC Number:
- 835-272-7
- Cas Number:
- 256374-76-2
- Molecular formula:
- C12H26N2O6P2
- IUPAC Name:
- 2-({2-[(5,5-dimethyl-2-oxo-1,3,2λ⁵-dioxaphosphinan-2-yl)amino]ethyl}amino)-5,5-dimethyl-1,3,2λ⁵-dioxaphosphinan-2-one
- Test material form:
- solid: particulate/powder
- Details on test material:
- Name
Name: Reaction products of ethane-1,2-diamine, phosphoryl=trichloride and 2,2-dimethylpropane-1,3-diol which makes N,N'-bis(5,5-dimethyl-1,3,2-dioxaphosphinane=2-oxide-2-yl)ethane-1,2-diamine as a main component
Other name: SH-0850
CAS number: 256374-76-2 (main component)
Structural formula
Molecular formula: C12H26N2O6P2 (main component)
Molecular weight: 356.29 (main component)
Provided sample
Purity of the test substance: 100%
Lot number: SK-241002
Physical-chemical properties
Solubility in water: Less than 0.03% (w/w) by visual observation
Melting point: 277 °C
Appearance at normal temperatures: White powder
Storage condition
The test substance was stored in a dark place at room temperature.
Precaution for handling
Protective gloves, mask, glasses and clothes were put on in order to avoid contacts with skin or eyes and inhalation.
Constituent 1
- Specific details on test material used for the study:
- No further details specified in the study report.
Method
- Target gene:
- histidine and tryptophan
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- Species and reason for selection
Salmonella typhimurium strains TA100, TA1535, TA98 and TA1537 were used as the tester strains in this study. Salmonella typhimurium strains were generously provided by Dr. Taijiro Matsushima, Japan Bioassay Research Center on March 13, 2003 and September 20, 2003, respectively. The use of these tester strains in the microbial mutagenicity test and bacterial reverse mutation test is recommended in “Public Notice stipulating the Standards determined by the Minister of Health, Labour and Welfare based on the provisions in Paragraph 1, Article 57-2 (current: Paragraph 1, Article 57-3) of the Industrial Safety and Health Law” and “Test Methods of the New Chemical Substances etc.”, and “OECD Guidelines for the Testing of Chemicals, No. 471, Bacterial Reverse Mutation Test”.
Storage
The tester strains were preliminarily checked for the amino acid requirement, ultraviolet sensitivity, rfa wall mutation, presence or absence of plasmid pKM101 and for the negative and positive control value. It was confirmed that these tester strains had the appropriate properties.
Dimethyl sulfoxide was mixed into the culture medium of the tester strains at a volume ratio of 10:0.9, and the mixtures were dispensed and stored as working stocks at -80 °C or below in an ultra-deep freezer 3 in Ames test room 1. The working stocks were freshly thawed before use. - Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- E. coli WP2 uvr A
- Details on mammalian cell type (if applicable):
- Species and reason for selection
Escherichia coli strain WP2uvrA was used as the tester strain in this study. Escherichia coli strain was generously provided by Dr. Taijiro Matsushima, Japan Bioassay Research Center on March 13, 2003 and September 20, 2003, respectively. The use of the tester strain in the microbial mutagenicity test and bacterial reverse mutation test is recommended in “Public Notice stipulating the Standards determined by the Minister of Health, Labour and Welfare based on the provisions in Paragraph 1, Article 57-2 (current: Paragraph 1, Article 57-3) of the Industrial Safety and Health Law” and “Test Methods of the New Chemical Substances etc.”, and “OECD Guidelines for the Testing of Chemicals, No. 471, Bacterial Reverse Mutation Test”.
Storage
The tester strain was preliminarily checked for the amino acid requirement, ultraviolet sensitivity, rfa wall mutation, presence or absence of plasmid pKM101 and for the negative and positive control value. It was confirmed that the tester strain had the appropriate properties. Dimethyl sulfoxide was mixed into the culture medium of the tester strains at a volume ratio of 10:0.9, and the mixtures were dispensed and stored as working stocks at -80 °C or below in an ultra-deep freezer 3 in Ames test room 1. The working stocks were freshly thawed before use. - Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
1) Rat liver S9
S9 (lot number 12090706, manufactured on September 7, 2012, Oriental Yeast Co., Ltd.,) prepared from the livers of 7-week old male SD rats (body weight: 208.5 ± 8.8 g) treated (intraperitoneal administration) with the combination of phenobarbital (single dose of 30 mg/kg and three doses of 60 mg/kg) and 5,6-benzoflavone (single dose of 80 mg/kg) was used. S9 was stored at -80 °C or below frozen in an ultra-deep freezer 3 in Ames test room 1 until use. The frozen S9 was freshly thawed just before use.
2) Composition of S9 mix
S9 mix was freshly prepared before use in the test. 1 mL of S9 mix contained 8 μM of MgCl2, 33 μM of KCl, 5 μM of glucose-6-phosphate, 4 μM of NADPH, 4 μM of NADH, 100 μM of sodium phosphate buffer (pH 7.4) and 0.1 mL of S9. - Test concentrations with justification for top dose:
- Based on the result of range-finding test, 5 dose levels by 2-fold serial dilutions were set from 5000 to 2500, 1250, 625 and 313μg/plate in the absence of S9 mix of any tester strains for Main test-1. In the presence of S9 mix, 5 dose levels by 2-fold serial dilutions were set from 5000 to 2500, 1250, 625 and 313μg/plate of any tester strains for Main test-1.
Main test-2
As the result of Main test-1, no increase to 2-fold or more over the negative control value in the number of revertant colonies was noted for all tester strains in the presence and absence of S9 mix. No growth inhibition was observed for any test conditions. Precipitation of the test substance was not observed in the presence and absence of S9 mix. Therefore, 5 dose levels by 2-fold serial dilutions were set from 5000 to 2500, 1250, 625 and 313 μg/plate of any tester strains for Main test-2. - Vehicle / solvent:
- Negative control substance (vehicle)
Name: DMSO
Manufacturer, lot number, purity and grade
Manufacturer: Dojindo Laboratories
Lot number: DB136
Purity: 99.9 %
Grade: Pure solvent for ultraviolet absorption spectrum
Reason for vehicle selection
The test substance was not soluble in distilled water (50.0 mg/mL) and acetone (100 mg/mL) but suspended in DMSO (50.0 mg/mL). Heat generation, bubbling and change of color tone were not observed for 50.0 mg/mL suspension using DMSO up to 2 hours after preparation at room temperature. Therefore, it was determined to be stable and DMSO was selected as vehicle.
Storage conditions
The vehicle was frozen (allowable range: -30 - -10 oC) and stored in Freezer 5 in Ames experiment Room 1.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- other: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide (AF-2); 2-Aminoanthracence (2AA); ICR-191
- Details on test system and experimental conditions:
- Experimental method
The tests were performed by the pre-incubation method in the absence and presence of S9 mix. Three plates were used for the negative control and 2 plates per dose level were used for each positive control and the test substance treatment groups in the dose-range finding test. In the main studies 3 plates per dose level were used for each negative control, positive control and test substance treatment groups. The study code number, the name of bacterial strain, presence or absence of S9 and the dose level were written on each plate for identification.
Operational procedure
In each operation, a mixture consisting of 0.1 mL of the test substance solution, the solvent or the positive control solution, 0.5 mL of 0.1 M sodium phosphate buffer (pH 7.4) or S9 mix and 0.1 mL of bacterial culture solution were added in a test tube and shook at 37 ± 0.5 °C for 20 minutes. 2 mL of the soft agar was then added to the test tube and the mixture was overlaid onto the surface of the plate. After the plate was incubated at 37 ± 0.5 °C for 48 hours, the number of revertant colonies formed on the plate was counted.
Sterility test
After 2 mL of soft agar was added to each of the test substance solution of the highest dose level (0.1 mL) and S9 mix (0.5 mL), these mixtures were overlaid onto the surface of the plates. The plates were incubated at 37 ± 0.5 °C for 48 hours and the presence or absence of contamination was determined for each plate.
Observation and counting
Observation
At the end of culture period, the presence or absence of precipitation of the test substance was determined by visual examination and the presence or absence of growth inhibition was determined using a stereoscopic microscope.
Counting
The number of colonies was counted using a colony analyzer (CA-11D, System Science Co., Ltd.,) for all plates. When using the colony analyzer, the colony count was corrected for the area and count loss and used as the number of revertant colony. - Rationale for test conditions:
- In accordance with test guidelines.
- Evaluation criteria:
- The test result was considered to be positive when the number of revertant colonies was increased to 2-fold or more over the negative control value and the mode of increase was dose dependent or reproducible, and all other test results were considered to be negative.
- Statistics:
- No statistical procedure was applied.
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:
- not applicable
- True negative controls validity:
- not applicable
- 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:
- not applicable
- True negative controls validity:
- not applicable
- 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:
- not applicable
- True negative controls validity:
- not applicable
- 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:
- not applicable
- True negative controls validity:
- not applicable
- 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:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- Dose-range finding test
There was no increase to 2-fold or more over the negative control value in the number of revertant colonies for TA100 in the absence of S9 mix. No growth inhibition was observed. Precipitation of the test substance was not observed.
Main test-1
There was no increase to 2-fold or more over the negative control value in the number of revertant colonies for all tester strains in the absence and presence of S9 mix. No growth inhibition was observed for any test conditions. Precipitation of the test substance was not observed in the absence and presence of S9 mix.
Main test-2
There was no increase to 2-fold or more over the negative control value in the number of revertant colonies for all tester strains in the absence and presence of S9 mix. No growth inhibition was observed for any test conditions. Precipitation of the test substance was not observed in the absence and presence of S9 mix.
Discussion
As the result of the tests, the number of revertant colonies was below 2-fold over the negative control value for all tester strains in the absence and presence of S9 mix. The mutagenicity of the test substance was judged negative.
The number of revertant colonies for positive control was 2-fold or more value over the negative control, and the numbers of revertant colonies for the negative control and positive controls were within the range of the historical data. Furthermore, the test system was found to be free of contamination. Therefore, it was judged that the study was performed properly.
Any other information on results incl. tables
Table of the test result (Main test-1)
Name of test substance: SH-0850
Test period |
From November 27, 2012 to November 30, 2012 |
|||||||||||
Presence or absence of metabolic activation |
Dose level of test substance (µg/plate) |
Number of reverse mutations (number of colonies) |
||||||||||
Base pair substitution type |
Frame shift type |
|||||||||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
||||||||
-S9 mix |
Negative control |
117 119 123 |
(120+/-3) |
17 11 11 |
(13+/-3) |
31 33 33 |
(32+/-1) |
24 19 19 |
(21+/-3) |
8 14 14 |
(12+/-3) |
|
313 |
136 130 146 |
(137+/-8) |
11 11 6 |
(9+/-3) |
32 31 28 |
(30+/-2) |
26 25 19 |
(23+/-4) |
6 19 13 |
(13+/-7) |
||
625 |
130 100 128 |
(119+/-17) |
6 12 10 |
(9+/-3) |
34 27 29 |
(30+/-4) |
15 15 20 |
(17+/-3) |
12 13 13 |
(13+/-1) |
||
1250 |
163 136 146 |
(148+/-26) |
11 13 12 |
(12+/-1) |
35 22 19 |
(25+/-9) |
19 29 24 |
(24+/-5) |
11 18 19 |
(16+/-4) |
||
2500 |
178 132 134 |
(148+/-26) |
11 13 12 |
(12+/-1) |
35 22 19 |
(25+/-9) |
19 29 24 |
(24+/-5) |
11 18 19 |
(16+/-4) |
||
5000 |
177 166 146 |
(163+/-16) |
12 6 7 |
(8+/-3) |
28 39 32 |
(33+/-6) |
28 21 19 |
(23+/-5) |
14 14 10 |
(13+/-2) |
||
+S9 mix |
Negative control |
122 105 119 |
(115+/-9) |
12 10 6 |
(9+/-3) |
39 33 27 |
(33+/-6) |
27 27 30 |
(25+/-4) |
20 17 11 |
(16+/-5) |
|
313 |
109 113 113 |
(112+/-2) |
14 6 12 |
(11+/-4) |
29 18 31 |
(26+/-7) |
39 31 35 |
(35+/-4) |
20 13 15 |
(16+/-4) |
||
625 |
132 140 115 |
(129+/-13) |
12 14 12 |
(13+/-1) |
34 20 24 |
(26+/-7) |
33 24 29 |
(29+/-5) |
18 22 15 |
(18+/-4) |
||
1250 |
118 108 132 |
(119+/-13) |
15 14 11 |
(13+/-2) |
29 19 33 |
(27+/-7) |
27 22 32 |
(27+/-5) |
14 11 15 |
(13+/-2) |
||
2500 |
111 130 129 |
(123+/-11) |
10 8 7 |
(8+/-2) |
34 34 22 |
(30+/-7) |
39 25 28 |
(31+/-7) |
15 13 21 |
(16+/-4) |
||
5000 |
115 147 144 |
(135+/-18) |
14 13 8 |
(12+/-3) |
32 29 45 |
(35+/-9) |
28 34 20 |
(27+/-7) |
21 13 12 |
(15+/-5) |
||
Positive control |
Positive control groups for which S9 mix is not necessary |
Name |
AF-2 |
NaN3 |
AF-2 |
AF-2 |
ICR-191 |
|||||
Dose (µg/plate) |
0.01 |
0.5 |
0.01 |
0.1 |
0.5 |
|||||||
(Number of colonies/plate) |
747 717 696 |
(720+/-26) |
311 289 307 |
(302+/-12) |
300 362 299 |
(320+/-36) |
473 513 513 |
(500+/-23) |
1810 1698 1769 |
(1759+/-57) |
||
Positive control groups for which S9 mix is necessary |
Name |
2AA |
2AA |
2AA |
2AA |
2AA |
||||||
Dose (µg/plate) |
1 |
2 |
10 |
0.5 |
2 |
|||||||
(Number of colonies/plate) |
693 701 732 |
(709+/-21) |
170 144 193 |
(169+/-25) |
772 682 689 |
(714+/-50) |
201 217 252 |
(223+/-26) |
119 103 107 |
(110+/-8) |
[Notes]
( ): Mean colony number +/- standard deviation (n=3)
AF-2: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide
NaN3: Sodium azide
2AA: 2-Aminoanthracene
Table of the test result (Main test-2)
Name of test substance: SH-0850
Test period |
From November 30, 2012 to December 3, 2012 |
|||||||||||
Presence or absence of metabolic activation |
Dose level of test substance (µg/plate) |
Number of reverse mutations (number of colonies) |
||||||||||
Base pair substitution type |
Frame shift type |
|||||||||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
||||||||
-S9 mix |
Negative control |
144 141 141 |
(142+/-2) |
11 12 18 |
(14+/-4) |
26 33 46 |
(35+/-10) |
27 15 21 |
(21+/-6) |
20 19 15 |
(18+/-3) |
|
313 |
144 146 164 |
(151+/-11) |
17 12 11 |
(13+/-3) |
46 32 41 |
(40+/-7) |
20 26 28 |
(25+/-4) |
8 17 14 |
(13+/-5) |
||
625 |
139 158 151 |
(149+/-10) |
18 14 18 |
(17+/-2) |
32 35 32 |
(33+/-2) |
26 19 32 |
(26+/-7) |
20 13 20 |
(18+/-4) |
||
1250 |
152 128 150 |
(143+/-13) |
11 10 14 |
(12+/-2) |
35 35 33 |
(34+/-1) |
21 20 18 |
(20+/-2) |
17 19 19 |
(18+/-1) |
||
2500 |
153 179 162 |
(165+/-13) |
21 11 15 |
(16+/-5)
|
40 34 26 |
(33+/-7) |
29 32 22 |
(28+/-5) |
10 21 14 |
(15+/-6) |
||
5000 |
210 217 178 |
(202+/-21) |
13 18 19 |
(17+/-3) |
34 32 38 |
(35+/-3) |
33 24 27 |
(28+/-5) |
20 11 14 |
(15+/-5) |
||
+S9 mix |
Negative control |
168 153 129 |
(150+/-20) |
14 17 18 |
(16+/-2) |
27 33 25 |
(28+/-4) |
36 40 26 |
(34+/-7) |
25 29 17 |
(24+/-6) |
|
313 |
123 135 144 |
(134+/-11) |
13 7 7 |
(9+/-3) |
45 41 48 |
(45+/-4) |
34 33 33 |
(33+/-1) |
21 29 29 |
(26+/-5) |
||
625 |
142 145 135 |
(140+/-6) |
13 6 18 |
(12+/-6) |
33 41 35 |
(36+/-4) |
33 34 31 |
(33+/-2) |
15 21 26 |
(21+/-6) |
||
1250 |
132 138 128 |
(132+/-6) |
13 8 14 |
(12+/-3) |
35 29 20 |
(28+/-8) |
40 41 21 |
(34+/-11) |
19 20 17 |
(19+/-2) |
||
2500 |
139 133 156 |
(143+/-12) |
7 12 14 |
(11+/-4) |
42 35 31 |
(36+/-6) |
21 35 28 |
(28+/-7) |
12 14 19 |
(15+/-4) |
||
5000 |
142 148 145 |
(145+/-3) |
10 11 14 |
(12+/-2) |
28 34 52 |
(38+/-12) |
25 38 34 |
(32+/-7) |
17 24 11 |
(17+/-7) |
||
Positive control |
Positive control groups for which S9 mix is not necessary |
Name |
AF-2 |
NaN3 |
AF-2 |
AF-2 |
ICR-191 |
|||||
Dose (µg/plate) |
0.01 |
0.5 |
0.01 |
0.1 |
0.5 |
|||||||
(Number of colonies/plate) |
786 797 727 |
(770+/-38) |
398 430 403 |
(410+/-17) |
343 401 397 |
(380+/-32) |
431 442 435 |
(436+/-6) |
2084 2138 2149 |
(2124+/-35) |
||
Positive control groups for which S9 mix is necessary |
Name |
2AA |
2AA |
2AA |
2AA |
2AA |
||||||
Dose (µg/plate) |
1 |
2 |
10 |
0.5 |
2 |
|||||||
(Number of colonies/plate) |
899 873 771 |
(848+/-68) |
215 218 214 |
(216+/-2) |
772 739 781 |
(764+/-22) |
255 250 235 |
(247+/-10) |
100 110 99 |
(103+/-6) |
[Notes]
( ): Mean colony number +/- standard deviation (n=3)
AF-2: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide
NaN3: Sodium azide
2AA: 2-Aminoanthracene
Historical data
Negative control (mean +/- 3S.D.)
|
-S9 mix |
+S9 mix |
||||||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
|
Mean
Standard deviation |
107
15 |
10
4 |
25
7 |
20
6 |
10
4 |
112
16 |
10
4 |
28
6 |
28
7 |
14
4 |
Highest count
Lowest count |
152
62 |
22
1 |
46
4 |
38
2 |
22
1 |
160
64 |
22
1 |
46
10 |
49
7 |
26
2 |
Positive control (mean +/- 3S.D.)
|
-S9 mix |
+S9 mix |
||||||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
|
Name |
AF-2 |
NaN3 |
AF-2 |
AF-2 |
ICR-191 |
2AA |
2AA |
2AA |
2AA |
2AA |
Dose level (µg/plate) |
0.01 |
0.5 |
0.01 |
0.1 |
0.5 |
1 |
2 |
10 |
0.5 |
2 |
Mean
Standard deviation |
737
85 |
255
65 |
315
44 |
522
80 |
1462
243 |
835
115 |
213
34 |
712
125 |
271
40 |
161
24 |
Highest count
Lowest count |
992
482 |
450
60 |
447
183 |
762
282 |
2191
733 |
1180
490 |
315
111 |
1087
337 |
391
151 |
233
89 |
[Notes]
AF-2: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide
NaN3: Sodium azide
2AA: 2-Aminoanthracene
Test period: From May, 2012 to October, 2012
Test media: AN medium was used.
Applicant's summary and conclusion
- Conclusions:
- It was concluded that SH-0850 is not mutagenic under the condition of the study.
- Executive summary:
The mutagenic potential of SH-0850 was assessed by the pre-incubation method in the absence and presence of the metabolic activation system (S9 mix) using the Salmonella typhimurium strains TA100, TA1535, TA98 and TA1537 and the Escherichia coli strain WP2uvrA.
The test result showed that the number of revertant colonies for all tester strains was less than two-fold of the negative control and the mutagenicity was considered to be negative.
Therefore, it was concluded that SH-0850 does not have mutagenic potential.
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