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EC number: 700-182-8 | CAS number: 134652-60-1
- 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
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- Nanomaterial pour density
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- Nanomaterial catalytic activity
- Endpoint summary
- Stability
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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
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- 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:
- 20 July to 30 August 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Recent study conducted by a GLP certified laboratory in accordance with a suitable study guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- TIS-M
- IUPAC Name:
- TIS-M
- Details on test material:
- - Name of test material: TIS-M
- Lot/batch No.: 3301 MS-0505-4
- Storage condition of test material: Under nitrogen at room temperature, in the dark.
Constituent 1
Method
- Target gene:
- Three mutant strains of Salmonella are incapable of synthesising histidine and are dependant on an external source of this particular amino acid for normal growth. When exposed to a mutagenic agent these bacteria may undergo a reverse mutation to histidine independant forms which are detected by their ability to grow on a histidine deficient medium. Using various strains of the organism, revertants produced after exposure to a chemical mutagen may arise as a result of base-pair substition in the genetic material (miscoding) or a frame-shift mutation in which the genetic material is inther added or deleted. In order to make the bacteria more sensitive to mutation by chemical and physical agents, several additional traits have been introduced. These include a deletion through the excision repair gene (uvrB- Salmonella strains) which renders the organism incapble of DNA excision repair and deep rough mutation (rfa) which increases the permeability of the cell wall. A mutant strain of Escherichia coli (WP2uvrA-) , which requires tryptophan and which can be reverse mutated by base substition to trytophan independence was used to complement Salmonella strains. This strain also has a deletion in an excision repair gene (uvrA-). Since many compounds do not exert a mutagenic effect until this have been metabolised by enzyme systems not available in the bacterial cell, the test material and the bacteria also incubated in the prescence of a (S9-mix) prepared from rats pre-treated with a mixture known to induce an elevated level of these enzymes.
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- other: Incapable of synthesising histidine.
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- other: Incapable of synthesising histidine.
- Metabolic activation:
- with and without
- Metabolic activation system:
- liver microsomal preparation S9-mix
- Test concentrations with justification for top dose:
- Preliminary toxicity test: 0, 0.15, 0.5, 1.5, 5, 15, 50, 150, 500, 1500 and 5000 µg/plate
Main Test: 50, 150, 500, 1500 and 5000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: acetone
- Justification for choice of solvent/vehicle: Information from sponsor advised against the use of sterile distilled water.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Remarks:
- 2-Aminoanthracene; Benzo(a)pyrene
- Positive controls:
- yes
- Positive control substance:
- other: N-ethyl-N'-nitro-nitrosoguanidine (ENNG); 9-Aminoacridine; 4-Nitroquinoline-1-oxide.
- Details on test system and experimental conditions:
- Tester strains:
The Salmonella strains were obtained from the University of California at Berkley on culture discs on August 4 1995 whilst Escherichia coli strain WP2uvra- was obtained from the British Industrial Biological Research Association on 17 August 1987. All strains were sotred at -196 °C in a Statebourne liquid nitrogen freezer, model SXR 34. Prior to the master strains being used, characterisation checks were carried out to confirm the amino-acid requirement, prescence of rfa, uvrB or uvrA mutation and the spontaneous reversion rate. In this assay, overnight subcultures of the appropriate coded stock cultures were prepared in nutrient broth (Oxoid Ltd; lot no: 350536 06/09) and incubated at 37 °C for approximately 10 hours. Each culture was monitored spectrophotometrically for turbidity with titres determined by viable count analysis on nutrient agar plates.
Preparation of Test and Control Materials:
The test material was immiscible in dimethyl sulphoxide at 50mg/ml but was fully miscible in acetone at the same concentration in solubility checks performed in-house. Acetone was used as the vehicle. The test material was accurately weighed and approximate half-log dilutions prepared in acetone by mixing on a vortex mixer on the day of each experiment. Analysis for concentration, homogenicity and stability of test material formualtions was not a requirement for the guideline so it was not carried out. Prior to use, the solvent was dried using molecular sieves (sodium alumino-silicate) i.e. 2mm pellets with a nominal pore diameter of 4x10^-4 microns.Vehicle and positive controls were used in parallel with the test material. A solvent treatment group was used as the vehicle control and the positive contol and positive control materials used in a series of plates without S9 -mix were as follows:
-N-ethyl-N'-nitro-N-nitrosoguanidine (ENNG): 3µg/plate for TA100, 5µg/plate for TA1535 and 2µg/plate for WP2uvrA-.
-9 -Aminoacridine (9AA): 80µg/plate for TA98
In addition, 2 -Aminoanthracene (2AA) and Benzo(a)pyrene (BP), which are non-mutagenic in the absence of metabolising enzymes, which were used in the series of plates with S9 -mix at the following concentrations:
-2AA at 1µg/plate for TA100
-2AA at 2µ/plate for TA1535 and TA1537
-BP at 5µg/plate for TA98.
-2AA at 10µg/plate for WPuvrA-
Microsomal enzyme fraction:
S9 was prepared in-house on 15 May 2005 (preliminary toxicity and range finding tests) and 10 July 2005 (main test) from the livers of male Sprague-dawley rats weighing ~ 250g. These had each orally recieved three consecutive daily doses of phenorbitone/β-napthoflavone (80/100 mg per kg per day) prior to S9 preparation on day 4. Before use, each batch of S9 was assayed for its ability to metabolise appropriate indirect mutagens used in the Ames test.
S9 -Mix and Agar:
The S9 -mix was prepared immediately before using sterilised co-factors and maintained on ice for the duration of thes test.
S9 - 5.0ml
1.65 M KCl/0.4M MgCl2 - 1.0ml
0.1M Glucose-6 -phosphate - 2.5ml
0.1M NADPH - 2.0ml
0.1M NADH - 2.0ml
0.2 M Sodium phosphate buffer (pH 7.4) - 25.0ml
Sterile distilled water - 12.5ml
A 0.5ml aliquot of S9 -mix and 2ml of molten, trace histidine or trytophan supplemente, top agar were overlaid onto a steri;e Vogel-Bonner Minimal agar plate in order to assess the sterility of the S9 -mix. This procedure was repeated, in triplicate, on the day of each experiment. Top agar was prepared using 0.6% Difco Bacto agar (lot no: 4348296 09/09) and 0.5% sodium chloride with 5ml of 1.0mM fistidine and 1.0mM biotin or 1.0mM trytophan solution added to each 100ml of top agar. Vogel-Bonner Minimal agar plates purchased from ILS Ltd. (Lot nos: 899855 -02 01/10 and 903393-02 02/10).
Method: Preliminary toxicity test:
The aim of the test was to select appropriate dose levels for the main test. The concentrations tested were 0, 0.15, 0.5, 1.5, 5, 15, 50, 150, 500, 1500 and 5000µg/plate. 0.1ml of the bacterial culture (TA100 or WP2uvrA-), 2ml of molten trace histidine or tryptophan supplemented, top agar, 0.1ml of the test material formulation and 0.5ml of S9 -mix or phosphate buffer were mixed, and were applied to sterile plates of Vogel Bonner Minimal agar (30ml/plate). 10 concentrations of the test material formulation and a vehicle control (acetone) were tested. 0.1ml of the maximum concentration of the test material and 2ml of molten, trace histidine or tryptophan supplemented, top agar were also overlaid onto a sterile Nutrient agar plate in order to assess the sterility of the test material. After approximately 48hrs incubation at 37 °C the plates were assessed for numbers of revertant colonies using a Domino colony counter and examined for effects on the growth of the bacterial background lawn.
Method: Main Test: Experiment 1:
Salmonella typhimurium strains TA1535, TA1537, TA98, TA 100 and Escherichia coli strain WP2uvrA- were treated with the test material using the Ames plate incorporation method at five dose levels (50, 150, 500, 1500 and 5000µg/plate), in triplicate, both with and without the addition of rat liver homogenate metabolising system (10% liver S9 in standard co-factors). Measured aliquots (0.1ml) of one of the bacterial cultures were dispensed into sets of test tubes followed by 2.0ml of molten, trace histidine or tryptophan supplemented, top agar, 0.1ml of the test formulation, vehicle or positive control, as well as either 0.5ml of S9 -mix or phosphate buffer.The dose range was determined in a preliminary toxicity assay and was 50 to 500µg/plate in the first experiment. The contents of each test tube were mixed and evenly distributed onto Vogel-Bonner Minimal agar plates (one tube per plate). Incubation was at 37 °C and lasted for 48hrs, after which the frequency of revertant colonies was assessed using a Domino colony counter.
Method: Main Test: Experiment 2:
The experiment was repeated on a separate day using the same dose range as experiment 1, fresh cultures of the bacterial strains and fresh test formulations.
Acceptance Criteria:
The reverse mutation assay may be considered to be valid if the following criteria are met:
-All tester strain cultures exhibit a characteristic noumber of spontaneous revertants per plate in the vehicle and untreated controls.
-The appropriate characteristics for each tester strain have been confirmed e.g. rfa cell-wall mutation and pKM101 plasmid R-factor etc.
-All tester strain cultures should be in the approximate range of 1 to 9.9 x 10^9 bacteria per ml.
- Each positive control value should be at least twice the respective vehicle control for each strain, thus demonstrating both the intrinsic sensitivity of the tester strains to mutagenic exposure and the integrity of the S9 -mix.
-There should be a minimum of 4 non-toxic material dose levels.
-There should be no evidence of excessive contamination.
METHOD OF APPLICATION: in agar
DURATION
- Preincubation period: no data
- Exposure duration: 3 days
NUMBER OF REPLICATIONS: 3 per concentration/vehicle control/positive and negative control - Evaluation criteria:
- There are several criteria for determining a positive result, such as a dose-related increase in revertant frequency over the dose range testes and/ora reproducible increase at one or more concentrations in at least one bacterial strain with or without metabolic activation. Biological relevence of the results will be considered first, statistical methods, as recommended by UKEMS can also be used to aid evaluation (not only determing factor). A testmaterial will be considered non-mutagenic (negative) if the test system if the above criteria are not met.
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
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- 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:
- See below.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Remarks on results:
Results for the negative controls (spontaneous mutation rates) were considered to be acceptable. The test material caused no visible reduction in the growth of the bacterial lawn at any dose level. The test material was therefore tested up the maximum recommended dose level of 5000µg/plate. An oily precipitate was obseved at 5000µg/plate but this did not prevent the scoring of revertant colonies. no significant increases in the frequency of revertant colonies were recorded for any of the strains of bacteria, at any dose level either with or without metabolic activation. All of the positive control chemicals used in the test induced marked increases in the frequency of revertant colonies, thus confirming the activity of the S9 -mix and the sensitivity of the bacterial strains.
Table 1: Preliminary toxicity test:
With (+) or without (-) S9-mix |
Strain |
Dose (µg/plate) |
||||||||||
0 |
0.15 |
0.5 |
1.5 |
5 |
15 |
50 |
150 |
500 |
1500 |
5000 |
||
- |
TA100 |
86 |
145 |
131 |
121 |
87 |
112 |
117 |
132 |
147 |
126 |
117P |
+ |
TA100 |
101 |
82 |
86 |
82 |
77 |
89 |
99 |
106 |
120 |
92 |
98P |
- |
WP2uvrA- |
24 |
24 |
22 |
24 |
19 |
20 |
18 |
27 |
23 |
13 |
20P |
+ |
WP2uvrA- |
41 |
36 |
33 |
29 |
29 |
33 |
38 |
36 |
41 |
37 |
37P |
Table 2: Main study: Spontaneuous Mutation Rates (Concurrent Negaative Controls): Experiment 1:
Number of revertants (mean number of colonies per plate) |
||||
Base-pair substitution type |
Frameshift type |
|||
TA100 |
TA1535 |
WP2uvrA- |
TA98 |
TA1537 |
71 |
15 |
21 |
13 |
2 |
60 (72) |
11 (14) |
28 (24) |
21 (18) |
8 (6) |
85 |
15 |
22 |
18 |
8 |
Table 2: Main study: Spontaneuous Mutation Rates (Concurrent Negaative Controls): Experiment 2:
Number of revertants (mean number of colonies per plate) |
||||
Base-pair substitution type |
Frameshift type |
|||
TA100 |
TA1535 |
WP2uvrA- |
TA98 |
TA1537 |
90 |
29 |
27 |
18 |
14 |
110 (103) |
30 (28) |
18 (22) |
13 (18) |
6 (8) |
109 |
24 |
22 |
22 |
5 |
Table 3: Main Study: Test Results: Experiment 1 - Without Metabolic Activation:
Test period |
From: 16 August 2005 |
To: 19 August 2005 |
||||
With or without S9-Mix |
Test substance concentration (µg) |
Number of revertants (mean number of colonies per plate) |
||||
Base Pair Substitution type |
Frameshift type |
|||||
TA100 |
TA1535 |
WP2uvrA- |
TA98 |
TA1537 |
||
- |
0 |
89 |
14 |
18 |
25 |
11 |
86 (86) |
10 (13) |
33 (23) |
16 (20) |
9 (10) |
||
82 3.5* |
15 2.6 |
19 8.4 |
18 4.7 |
11 1.2 |
||
- |
50 |
102 |
13 |
19 |
27 |
9 |
91 (93) |
10 (14) |
16 (20) |
19 (24) |
14 (11) |
||
86 8.2 |
18 4.0 |
25 4.6 |
25 4.2 |
10 2.6 |
||
- |
150 |
97 |
13 |
31 |
14 |
8 |
101 (99) |
10 (15) |
19 (23) |
14 (13) |
13 (11) |
||
98 2.1 |
23 6.8 |
18 7.2 |
11 1.7 |
13 2.9 |
||
- |
500 |
81 |
11 |
18 |
24 |
8 |
104 (101) |
11 (12) |
22 (21) |
23 (22) |
14 (9) |
||
117 18.2 |
15 2.3 |
23 2.6 |
18 3.2 |
6 4.2 |
||
- |
1500 |
105 |
14 |
17 |
21 |
13 |
110 (106) |
26 (19) |
25 (19) |
32 (28) |
15 (12) |
||
102 4.0 |
17 6.2 |
15 5.3 |
32 6.4 |
9 3.1 |
||
- |
5000 |
87P |
15P |
28P |
24P |
8P |
101P (103) |
10P (15) |
28P (26) |
21P (25) |
8P (9) |
||
121P 17.1 |
19P 4.5 |
22P 3.5 |
29P 4.0 |
10P 1.2 |
||
Positive Controls
S9-Mix - |
Name Concentration (µg/plate) No. colonies per plate |
ENNG |
ENNG |
ENNG |
4NQO |
9AA |
3 |
5 |
2 |
0.2 |
80 |
||
283 225 (261) 276 31.7 |
136 134 (138) 145 5.9 |
521 452 (466) 424 49.9 |
162 123 (147) 156 21.0 |
634 296 (434) 372 177.3 |
- ENNG = N-ethyl-N'-nitro-N-nitrosguanidine
- 4NQO = 4 -Nitroquinoline-1 -oxide
- 9AA = 9 -Aminoacridine
- P = precipitate.
- * = standard deviation
Table 4: Main Study: Test Results: Experiment 1 - With Metabolic Activation:
Test period |
From: 16 August 2005 |
To: 19 August 2005 |
||||
With or without S9-Mix |
Test substance concentration (µg) |
Number of revertants (mean number of colonies per plate) |
||||
Base Pair Substitution type |
Frameshift type |
|||||
TA100 |
TA1535 |
WP2uvrA- |
TA98 |
TA1537 |
||
+ |
0 |
92 |
13 |
26 |
23 |
11 |
70 (79) |
13 (11) |
26 (29) |
26 (27) |
11 (11) |
||
74 11.7* |
8 2.9 |
34 4.6 |
31 4.0 |
11 0.0 |
||
+ |
50 |
64 |
8 |
20 |
33 |
13 |
82 (77) |
9 (9) |
23 (22) |
28 (27) |
10 (10) |
||
86 11.7 |
9 0.6 |
24 2.1 |
19 7.1 |
8 2.5 |
||
+ |
150 |
67 |
9 |
18 |
28 |
11 |
70 (71) |
13 (13) |
22 (22) |
19 (22) |
18 (14) |
||
77 5.1 |
17 4.0 |
26 4.0 |
20 4.9 |
13 3.6 |
||
+ |
500 |
96 |
11 |
25 |
34 |
10 |
97 (94) |
16 (12) |
36 (30) |
33 (33) |
9 (11) |
||
88 4.9 |
8 4.0 |
28 5.7 |
33 0.6 |
14 2.6 |
||
+ |
1500 |
102 |
14 |
21 |
29 |
4 |
85 (98) |
10 (11) |
28 (27) |
20 (23) |
5 (6) |
||
107 11.5 |
10 2.3 |
32 5.6 |
20 5.2 |
10 3.2 |
||
+ |
5000 |
91P |
16P |
36P |
32P |
11P |
105P (94) |
11P (14) |
25P (31) |
33P (35) |
13P (12) |
||
86P 9.8 |
14P 2.5 |
31P 5.5 |
39P 3.8 |
111P 1.2 |
||
Positive Controls
S9-Mix + |
Name Concentration (µg/plate) No. colonies per plate |
2AA |
2AA |
2AA |
BP |
2AA |
1 |
2 |
10 |
5 |
2 |
||
1024 713 (951) 1117 211.6 |
170 176 (174) 176 3.5 |
237 255 (251) 260 12.1 |
126 118 (115) 101 12.8 |
258 113 (177) 160 74.0 |
- 2AA = 2 -Aminoanthracene
- BP = Benzo(a)pyrene
- P = Precipitate
- * = Standard Deviation
Table 5: Main Study: Test Results: Experiment 2 - Without Metabolic Activation:
Test period |
From: 26 August 2005 |
To: 29 August 2005 |
||||
With or without S9-Mix |
Test substance concentration (µg) |
Number of revertants (mean number of colonies per plate) |
||||
Base Pair Substitution type |
Frameshift type |
|||||
TA100 |
TA1535 |
WP2uvrA- |
TA98 |
TA1537 |
||
- |
0 |
104 |
18 |
32 |
19 |
14 |
102 (101) |
19 (19) |
22 (25) |
20 (20) |
14 (12) |
||
98 3.1* |
21 1.5 |
21 6.1 |
22 1.5 |
9 2.9 |
||
- |
50 |
96 |
20 |
26 |
16 |
2 |
95 (96) |
18 (17) |
24 (24) |
22 (20) |
11 (11) |
||
100 2.6 |
14 3.1 |
23 1.5 |
23 3.8 |
11 0.6 |
||
- |
150 |
76 |
14 |
29 |
23 |
9 |
106 (98) |
14 (15) |
22 (29) |
25 (22) |
10 (10) |
||
112 19.3 |
16 1.2 |
35 6.5 |
19 3.1 |
10 0.6 |
||
- |
500 |
91 |
14 |
21 |
16 |
8 |
95 (99) |
16 (16) |
25 (25) |
18 (19) |
9 (9) |
||
112 11.2 |
19 2.5 |
30 4.5 |
22 3.1 |
11 1.5 |
||
- |
1500 |
86 |
16 |
16 |
22 |
9 |
99 (94) |
15 (16) |
29 (22) |
18 (20) |
9 (9) |
||
98 10.8 |
16 0.6 |
21 6.6 |
21 2.1 |
10 0.6 |
||
- |
5000 |
87P |
13P |
25P |
19P |
13P |
104P (99) |
18P (15) |
18P (22) |
16P (19) |
8P (10) |
||
107P 10.8 |
15P 2.5 |
23P 3.6 |
23P 3.5 |
9P 2.6 |
||
Positive Controls
S9-Mix - |
Name Concentration (µg/plate) No. colonies per plate |
ENNG |
ENNG |
ENNG |
4NQO |
9AA |
3 |
5 |
2 |
0.2 |
80 |
||
491 406 (437) 414 46.9 |
211 196 (280) 434 133.3 |
710 605 (664) 678 53.8 |
173 191 (200) 236 32.4 |
733 214 (404) 264 286.3 |
- ENNG = N-ethyl-N'-nitro-N-nitrosguanidine
- 4NQO = 4 -Nitroquinoline-1 -oxide
- 9AA = 9 -Aminoacridine
- P = precipitate.
- * = standard deviation
Table 6: Main Study: Test Results: Experiment 2 - With Metabolic Activation:
Test period |
From: 26 August 2005 |
To: 29 August 2005 |
||||
With or without S9-Mix |
Test substance concentration (µg) |
Number of revertants (mean number of colonies per plate) |
||||
Base Pair Substitution type |
Frameshift type |
|||||
TA100 |
TA1535 |
WP2uvrA- |
TA98 |
TA1537 |
||
+ |
0 |
87 |
12 |
36 |
23 |
20 |
77 (88) |
12 (12) |
38 (39) |
41 (32) |
21 (21) |
||
100 11.5* |
12 0.0 |
44 4.2 |
31 9.0 |
23 1.5 |
||
+ |
50 |
93 |
12 |
31 |
24 |
16 |
85 (96) |
10 (11) |
31 (35) |
34 (80) |
18 (17) |
||
87 4.2 |
11 1.0 |
42 6.4 |
27 5.1 |
18 1.2 |
||
+ |
150 |
75 |
13 |
32 |
34 |
15 |
79 (82) |
12 (12) |
30 (30) |
36 (34) |
16 (17) |
||
92 8.9 |
12 0.6 |
29 1.5 |
31 2.5 |
19 2.1 |
||
+ |
500 |
98 |
12 |
30 |
37 |
14 |
91 (95) |
11 (12) |
41 (35) |
36 (34) |
18 (16) |
||
95 3.5 |
13 1.0 |
35 5.5 |
30 3.8 |
15 2.1 |
||
+ |
1500 |
89 |
12 |
37 |
35 |
16 |
88 (93) |
10 (11) |
34 (36) |
30 (30) |
19 (18) |
||
102 7.8 |
10 1.2 |
36 1.5 |
26 4.5 |
20 2.1 |
||
+ |
5000 |
98P |
15P |
38P |
31P |
20P |
87P (95) |
12P (13) |
35P (39) |
27P (30) |
22P (21) |
||
99P 6.7 |
11P 2.1 |
44P 4.6 |
33P 3.1 |
21P 1.0 |
||
Positive Controls
S9-Mix + |
Name Concentration (µg/plate) No. colonies per plate |
2AA |
2AA |
2AA |
BP |
2AA |
1 |
2 |
10 |
5 |
2 |
||
1218 1061(1083) 971 125.0 |
246 196 (209) 186 32.1 |
631 611 (664) 567 53.8 |
187 201 (187) 174 13.5 |
374 306 (326) 297 42.1 |
- ENNG = N-ethyl-N'-nitro-N-nitrosguanidine
- 4NQO = 4 -Nitroquinoline-1 -oxide
- 9AA = 9 -Aminoacridine
- P = precipitate.
- * = standard deviation
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The registered substance was determined to be non-mutagenic. - Executive summary:
A genetic study of the substance was carried out according to EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria) using Salmonella typhimurium TA 1535, TA 1537, TA 98 and TA 100 and Escherichia coli WP2 uvr A.
The registered substance and the bacteria were applied to agar and after 3 days the substance was determined to be non-mutagenic.
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