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EC number: 916-222-4 | 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:
- key study
- Study period:
- 02.02.2000-29.03.2000
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5265 (The Salmonella typhimurium Bacterial Reverse Mutation Test)
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reaction mass of N,N'-ethylenebis[N-methyl-2-[(1-oxo-9-octadecenyl)oxy]-N-[2-[(1-oxo-9-octadecenyl)oxy]propyl]propylammonium] dimethyl disulphate and [2-[bis(2-hydroxypropyl)amino]ethyl]bis(2-hydroxypropyl)(methyl)ammonium methyl sulphate, dioleate (ester)
- EC Number:
- 916-222-4
- Molecular formula:
- C51H99N2O6.CH3O4S
- IUPAC Name:
- Reaction mass of N,N'-ethylenebis[N-methyl-2-[(1-oxo-9-octadecenyl)oxy]-N-[2-[(1-oxo-9-octadecenyl)oxy]propyl]propylammonium] dimethyl disulphate and [2-[bis(2-hydroxypropyl)amino]ethyl]bis(2-hydroxypropyl)(methyl)ammonium methyl sulphate, dioleate (ester)
- Reference substance name:
- Propane-1,2-diol
- EC Number:
- 200-338-0
- EC Name:
- Propane-1,2-diol
- Cas Number:
- 57-55-6
- Molecular formula:
- C3H8O2
- IUPAC Name:
- propylene glycol
Constituent 1
additive 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 134428
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark
- Stability under test conditions: stable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test material was accurately weighed and approximate half-log dilutions prepared in dimethyl sulphoxide by mixing on a vortex mixer and sonication for 5 minutes at 40 C on the day of each experiment. An allowance for test material purity (94%) was made prior to formulation for the first and second experiments. Analysis for concentration, homogeneity and stability of the test material formulations is not a requirement of the test guidelines and was, therefore, not determined. Prior to use , the solvent was dried using molecular sieves (sodium alumino-silicate) ie 2mm pellets with a nominal pore diameter of 4x10^-4 microns.
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Test concentrations with justification for top dose:
- Salmonella strains with S9: 5,15,50,150, 500 and 1500 ug/plate
Salmonella strains without S9: 1.5, 5, 15, 50, 150 and 500 ug/plate
Escherichia coli strain WP2uvrA with and without S9: 15,50, 150, 500, 1500 and 5000 ug/plate
Justification for top dose: toxicity. Minimum of four non-toxic doses were plated. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- benzo(a)pyrene
- other: 2-Aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
- Cell density at seeding (if applicable): 1 to 9.9 x 10^9 per mL
DURATION
- Preincubation period: 10 hours
- Exposure duration: 48 hours
NUMBER OF REPLICATIONS: 3
NUMBER OF CELLS EVALUATED: 1 to 9.9 x 10^9 per mL - Evaluation criteria:
- The test material may be considered positive in this test system if the following criteria are met:
The test material should have induced a reproducible, dose-related and statistically (Dunnett´s method of linear regression(5)) significant increase in the recertant count in at least one strain of bacteria. - Statistics:
- Dunnett's method
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- 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:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- 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 specified
- Positive controls validity:
- valid
Any other information on results incl. tables
The number of revertant colonies for the toxicity assay | ||||||||||||
With (+) or without (-) S9-mix | Strain | Dose (µg/plate) | ||||||||||
0 | 0.15 | 0.5 | 1.5 | 5 | 15 | 50 | 150 | 500 | 1500 | 5000 | ||
- | TA100 | 127 | 141 | 131 | 132 | 143 | 115 | 108 | 595 | 0V | C | 0T |
+ | TA100 | 121 | 99 | 109 | 118 | 126 | 126 | 143 | 136 | 118 | 0T | 0T |
- | WP2uvrA | 23 | 22 | 19 | 19 | 17 | 17 | 22 | 26 | 25 | 125 | 0T |
+ | WP2uvrA | 18 | 26 | 25 | 23 | 25 | 23 | 26 | 37 | 24 | 19 | 0V |
C = contaminated | ||||||||||||
S = sparse bacterial background lawn | ||||||||||||
T = toxic, no bacterial background lawn | ||||||||||||
V = very weak bacterial background lawn |
EXP 1 | |||||||||
Number of revertants (mean number of colonies per plate) | |||||||||
Base-pair substitution type | Frameshift type | ||||||||
TA100 | TA1535 | WP2uvrA | TA98 | TA1537 | |||||
143 | 16 | 31 | 40 | 9 | |||||
167 | (150) | 22 | (20) | 28 | (27) | 23 | (30) | 9 | (12) |
139 | 23 | 22 | 26 | 17 |
EXP 2 | |||||||||
Number of revertants (mean number of colonies per plate) | |||||||||
Base-pair substitution type | Frameshift type | ||||||||
TA100 | TA1535 | WP2uvrA | TA98 | TA1537 | |||||
148 | 12 | 28 | 13 | 7 | |||||
125 | (136) | 18 | (14) | 44 | (36) | 15 | (16) | 13 | (10) |
136 | 13 | 37 | 21 | 11 |
TABLE 2 | |||||||||||
With or without S9-mix | Test substance concentration (µg/plate) | Number of revertants (mean number of colonies per plate) | |||||||||
Base-pair substitution type | Frameshift type | ||||||||||
TA100 | TA1535 | WP2uvrA | TA98 | TA1537 | |||||||
- | 0 | 170 | (154) | 20 | (25) | 34 | (24) | 28 | (28) | 13 | (12) |
136 | 17.0# | 31 | 5.5 | 20 | 8.7 | 25 | 3.0 | 8 | 3.2 | ||
155 | 25 | 18 | 31 | 14 | |||||||
- | 1.5 | 117 | (130) | 19 | (22) | N/T | 25 | (32) | 11 | (10) | |
145 | 14.1 | 26 | 3.8 | 38 | 6.5 | 11 | 2.3 | ||||
128 | 20 | 32 | 7 | ||||||||
- | 5 | 127 | (136) | 21 | (17) | N/T | 22 | (29) | 13 | (10) | |
136 | 8.5 | 14 | 3.6 | 27 | 8.7 | 11 | 3.1 | ||||
144 | 16 | 39 | 7 | ||||||||
- | 15 | 146 | (143) | 15 | (21) | 22 | (22) | 28 | (31) | 15 | (14) |
141 | 2.5 | 25 | 5.3 | 22 | 0.6 | 36 | 4.6 | 13 | 1.0 | ||
143 | 23 | 21 | 28 | 14 | |||||||
- | 50 | 115 | (134) | 24 | (27) | 21 | (23) | 36 | (26) | 11 | (14) |
139 | 17.5 | 25 | 4.9 | 27 | 3.5 | 17 | 9.5 | 21 | 5.8 | ||
149 | 33 | 21 | 26 | 11 | |||||||
- | 150 | 48 | (57) | 22 | (18) | 34 | (26) | C | (24) | 17 | (16) |
55 | 9.6 | 14 | 4.0 | 25 | 7.5 | 27 | 4.9 | 11 | 4.6 | ||
67 | 19 | 19 | 20 | 20 | |||||||
- | 500 | 0V | (0) | 0V | (0) | 22 | (21) | 18S | (14) | 0V | (0) |
0V | 0.0 | 0V | 0.0 | 22 | 2.3 | 9S | 4.6 | 0V | 0.0 | ||
0V | 0V | 18 | 15S | 0V | |||||||
- | 1500 | N/T | N/T | 0V | (0) | N/T | N/T | ||||
0V | 0.0 | ||||||||||
0V | |||||||||||
- | 5000 | N/T | N/T | 0T | (0) | N/T | N/T | ||||
0T | 0.0 | ||||||||||
0T | |||||||||||
Positive controls S9-Mix - |
Name | ENNG | ENNG | ENNG | 4NQO | 9AA | |||||
Concentration (µg/plate) | 3 | 5 | 2 | 0.2 | 80 | ||||||
No. Colonies per plate | 412 | (396) | 153 | (154) | 382 | (374) | 131 | (123) | 1085 | (980) | |
370 | 22.5 | 156 | 2.1 | 344 | 26.9 | 102 | 18.0 | 1082 | 179.3 | ||
405 | 152 | 396 | 135 | 773 | |||||||
ENNG | N-ethyl-N´-nitro-N-nitrosoguanidine | N/T | Not tested at this dose level | ||||||||
4NQO | 4-Nitroquinoline-1-oxide | S | Sparse bacterial background lawn | ||||||||
# | Standard deviation | T | Toxic, no bacterial background lawn | ||||||||
C | Contaminated | V | Very weak bacterial background lawn |
TABLE 3 | |||||||||||
With or without S9-mix | Test substnace concentration (µg/plate) | Number of revertants (mean number of colonies per plate) | |||||||||
Base-pair substitution type | Frameshift type | ||||||||||
TA100 | TA1535 | WP2uvrA | TA98 | TA1537 | |||||||
+ | 0 | 154 | (151) | 10 | (15) | 26 | (25) | 39 | (34) | 19 | (15) |
137 | 13.2# | 19 | 4.7 | 22 | 3.1 | 36 | 6.8 | 15 | 4.0 | ||
163 | 17 | 28 | 26 | 11 | |||||||
+ | 5 | 162 | (153) | 11 | (13) | N/T | 37 | (40) | 14 | (15) | |
156 | 10.3 | 14 | 2.1 | 49 | 7.9 | 17 | 2.1 | ||||
142 | 15 | 34 | 13 | ||||||||
+ | 15 | 143 | (138) | 18 | (15) | 25 | (23) | 31 | (33) | 9 | (11) |
132 | 5.7 | 13 | 2.6 | 21 | 2.1 | 39 | 4.9 | 12 | 1.5 | ||
140 | 14 | 24 | 30 | 11 | |||||||
+ | 50 | 161 | (151) | 18 | (17) | 24 | (22) | 39 | (36) | 14 | (13) |
138 | 11.8 | 17 | 1.5 | 21 | 2.1 | 42 | 8.5 | 16 | 4.2 | ||
154 | 15 | 20 | 26 | 8 | |||||||
+ | 150 | 144 | (155) | 10 | (12) | 20 | (19) | 41 | (43) | 13 | (14) |
163 | 9.8 | 8 | 5.3 | 21 | 2.6 | 44 | 1.7 | 12 | 3.2 | ||
158 | 18 | 16 | 44 | 18 | |||||||
+ | 500 | 22 | (17) | 11 | (9) | 23 | (25) | 41 | (40) | 10 | (10) |
16 | 4.6 | 4 | 4.7 | 26 | 1.5 | 40 | 1.5 | 14 | 4.0 | ||
13 | 13 | 25 | 38 | 6 | |||||||
+ | 1500 | 0V | (0) | 0V | (0) | 23V | (21) | 0V | (0) | 0V | (0) |
0V | 0 | 0V | 0 | 17V | 3.8 | 0V | 0 | 0V | 0 | ||
0V | 0V | 24V | 0V | 0V | |||||||
+ | 5000 | N/T | N/T | 0T | (0) | N/T | N/T | ||||
0T | 0.0 | ||||||||||
0T | |||||||||||
Positive controls S9-Mix + |
Name | 2AA | 2AA | 2AA | BP | 2AA | |||||
Concentration (µg/plate) | 1 | 2 | 10 | 5 | 2 | ||||||
No. Colonies per plate | 2212 | (1876) | 301 | (307) | 1001 | (929) | 407 | (376) | 513 | (584) | |
1695 | 291.0 | 296 | 14.9 | 877 | 31.0 | 376 | 31.0 | 619 | 61.2 | ||
1722 | 324 | 908 | 345 | 619 | |||||||
BP | Benzo(a)pyrene | N/T | Not tested at this dose level | ||||||||
2AA | 2-Aminoanthracene | T | Toxic, no bacterial background lawn | ||||||||
# | Standard deviation | V | Very weak bacterial background lawn |
TABLE 4 | |||||||||||
With or without S9-mix | Test substnace concentration (µg/plate) | Number of revertants (mean number of colonies per plate) | |||||||||
Base-pair substitution type | Frameshift type | ||||||||||
TA100 | TA1535 | WP2uvrA | TA98 | TA1537 | |||||||
- | 0 | 149 | (138) | 15 | (17) | 35 | (43) | 23 | (20) | 5 | (8) |
125 | 12.2# | 20 | 2.9 | 56 | 11.2 | 15 | 4.2 | 9 | 3.1 | ||
141 | 15 | 39 | 21 | 11 | |||||||
- | 1.5 | 137 | (144) | 22 | (18) | N/T | N/T | 5 | (8) | ||
159 | 13.0 | 20 | 5.3 | 11 | 3.1 | ||||||
136 | 12 | 9 | |||||||||
- | 5 | 148 | (138) | 19 | (17) | N/T | 22 | (21) | 16 | (10) | |
133 | 8.4 | 15 | 2.1 | 20 | 1.2 | 7 | 5.2 | ||||
134 | 16 | 20 | 7 | ||||||||
- | 15 | 124 | (141) | 21 | (17) | 34 | (33) | 18 | (19) | 16 | (11) |
151 | 14.8 | 15 | 3.2 | 32 | 1.2 | 26 | 6.1 | 10 | 4.6 | ||
148 | 16 | 32 | 14 | 7 | |||||||
- | 50 | 158 | (151) | 19 | (18) | 34 | (35) | 21 | (20) | 10 | (8) |
155 | 10.2 | 20 | 2.6 | 36 | 1.2 | 21 | 1.7 | 7 | 1.5 | ||
139 | 15 | 36 | 18 | 7 | |||||||
- | 150 | 81 | (71) | 11 | (11) | 36 | (38) | 24 | (24) | 11 | (9) |
76 | 12.7 | 6 | 5.0 | 35 | 3.8 | 23 | 0.6 | 8 | 1.5 | ||
57 | 16 | 42 | 24 | 9 | |||||||
- | 500 | 0V | (0) | 0V | (0) | 32 | (39) | 9S | (9) | 0V | (0) |
0V | 0.0 | 0V | 0.0 | 45 | 6.6 | 11S | 1.5 | 0V | 0.0 | ||
0V | 0V | 40 | 8S | 0V | |||||||
- | 1500 | N/T | N/T | 0V | (0) | 0V | (0) | N/T | |||
0V | 0.0 | 0V | 0.0 | ||||||||
0V | 0V | ||||||||||
- | 5000 | N/T | N/T | 0T | (0) | N/T | N/T | ||||
0T | 0.0 | ||||||||||
0T | |||||||||||
Positive controls S9-Mix - |
Name | ENNG | ENNG | ENNG | 4NQO | 9AA | |||||
Concentration (µg/plate) | 3 | 5 | 2 | 0.2 | 80 | ||||||
No. Colonies per plate | 393 | (413) | 298 | (299) | 737 | (740) | 104 | (105) | 1323 | (1399) | |
396 | 32.7 | 284 | 16.0 | 755 | 14.2 | 110 | 4.2 | 1392 | 79.7 | ||
451 | 316 | 727 | 102 | 1482 | |||||||
ENNG | N-ethyl-N´-nitro-N-nitrosoguanidine | N/T | Not tested at this dose level | ||||||||
4NQO | 4-Nitroquinoline-1-oxide | S | Sparse bacterial background lawn | ||||||||
# | Standard deviation | T | Toxic, no bacterial background lawn | ||||||||
C | Contaminated | V | Very weak bacterial background lawn |
TABLE 5 | |||||||||||
With or without S9-mix | Test substnace concentration (µg/plate) | Number of revertants (mean number of colonies per plate) | |||||||||
Base-pair substitution type | Frameshift type | ||||||||||
TA100 | TA1535 | WP2uvrA | TA98 | TA1537 | |||||||
+ | 0 | 98 | (124) | 13 | (12) | 37 | (44) | 36 | (34) | 16 | (13) |
148 | 25.1# | 12 | 0.6 | 56 | 10.2 | 36 | 4.0 | 16 | 5.2 | ||
126 | 12 | 40 | 29 | 7 | |||||||
+ | 5 | 170 | (148) | 10 | (11) | N/T | 32 | (32) | 15 | (13) | |
137 | 19.1 | 12 | 1.2 | 32 | 0.6 | 15 | 3.5 | ||||
137 | 10 | 33 | 9 | ||||||||
+ | 15 | 130 | (134) | 11 | (10) | 36 | (39) | 36 | (34) | 13 | (12) |
143 | 7.5 | 8 | 1.7 | 45 | 4.9 | 35 | 2.1 | 11 | 1.0 | ||
130 | 11 | 37 | 32 | 12 | |||||||
+ | 50 | 148 | (146) | 20 | (16) | 36 | (37) | 24 | (26) | 13 | (13) |
162 | 16.6 | 16 | 4.5 | 36 | 2.3 | 24 | 3.5 | 17 | 3.5 | ||
129 | 11 | 40 | 30 | 10 | |||||||
+ | 150 | 143 | (146) | 10 | (11) | 48 | (36) | 32 | (29) | 14 | (12) |
127 | 20.7 | 13 | 1.5 | 23 | 12.6 | 32 | 5.2 | 18 | 6.7 | ||
168 | 11 | 38 | 23 | 5 | |||||||
+ | 500 | 31 | (29) | 13 | (9) | 41 | (41) | 31 | (28) | 6 | (8) |
23 | 5.7 | 8 | 3.2 | 46 | 4.5 | 30 | 3.8 | 9 | 1.5 | ||
34 | 7 | 37 | 24 | 8 | |||||||
+ | 1500 | 0V | 0 | 0V | 0 | 35 | (38) | 0V | 0 | 0V | 0 |
0V | 0.0 | 0V | 0.0 | 32 | 8.5 | 0V | 0.0 | 0V | 0.0 | ||
0V | 0V | 48 | 0V | 0V | |||||||
+ | 5000 | N/T | N/T | 0T | (0) | N/T | N/T | ||||
0T | 0.0 | ||||||||||
0T | |||||||||||
Positive controls S9-Mix + |
Name | 2AA | 2AA | 2AA | BP | 2AA | |||||
Concentration (µg/plate) | 1 | 2 | 10 | 5 | 2 | ||||||
No. Colonies per plate | 1722 | (1659) | 334 | (325) | 622 | (586) | 297 | (289) | 518 | (390) | |
1744 | 128.6 | 350 | 31.8 | 572 | 31.8 | 261 | 25.4 | 345 | 112.1 | ||
1511 | 291 | 563 | 310 | 308 | |||||||
BP | Benzo(a)pyrene | N/T | Not tested at this dose level | ||||||||
2AA | 2-Aminoanthracene | T | Toxic, no bacterial background lawn | ||||||||
# | Standard deviation | V | Very weak bacterial background lawn |
Historical Profile - Vehicle Control Values 1998 | ||||||||||||||
Strain | TA100 | TA98 | TA1535 | TA1538 | TA1537 | WP2uvrA | TA102 | |||||||
S9-Mix | -S9 | + S9 | -S9 | + S9 | -S9 | + S9 | -S9 | + S9 | -S9 | + S9 | -S9 | + S9 | -S9 | + S9 |
Mean | 124 | 125 | 31 | 36 | 26 | 18 | 26 | 28 | 11 | 14 | 23 | 25 | 262 | 285 |
SD | 16 | 16 | 6 | 6 | 5 | 4 | 6 | 5 | 3 | 3 | 4 | 4 | 31 | 32 |
Min | 73 | 81 | 15 | 22 | 12 | 10 | 15 | 18 | 5 | 6 | 13 | 13 | 191 | 231 |
Max | 173 | 170 | 45 | 54 | 38 | 37 | 26 | 26 | 20 | 23 | 34 | 41 | 304 | 363 |
Values | 342 | 339 | 337 | 340 | 341 | 331 | 16 | 16 | 323 | 325 | 287 | 285 | 20 | 22 |
Historical Profile - Positive Control Values 1998 | ||||||||||||||
Strain | TA100 | TA98 | TA1535 | TA1538 | TA1537 | WP2uvrA | TA102 | |||||||
S9-Mix | -S9 | + S9 | -S9 | + S9 | -S9 | + S9 | -S9 | + S9 | -S9 | + S9 | -S9 | + S9 | -S9 | + S9 |
Mean | 556 | 1209 | 143 | 472 | 375 | 260 | 403 | 556 | 1052 | 298 | 851 | 837 | 863 | 747 |
SD | 114 | 318 | 24 | 119 | 173 | 64 | 93 | 197 | 259 | 106 | 202 | 223 | 127 | 116 |
Min | 349 | 681 | 101 | 198 | 112 | 105 | 305 | 344 | 173 | 123 | 415 | 260 | 646 | 591 |
Max | 1147 | 2740 | 225 | 733 | 1143 | 601 | 604 | 1073 | 1912 | 652 | 1486 | 1380 | 1096 | 1096 |
Values | 141 | 141 | 140 | 143 | 142 | 141 | 12 | 12 | 142 | 141 | 138 | 138 | 24 | 25 |
Historical Profile - Vehicle Control Values 1999 | ||||||||||||||
Strain | TA100 | TA98 | TA1535 | TA1538 | TA1537 | WP2uvrA | TA102 | |||||||
S9-Mix | -S9 | + S9 | -S9 | + S9 | -S9 | + S9 | -S9 | + S9 | -S9 | + S9 | -S9 | + S9 | -S9 | + S9 |
Mean | 102 | 107 | 24 | 31 | 22 | 16 | 13 | 19 | 11 | 17 | 23 | 27 | 263 | 298 |
SD | 19 | 20 | 6 | 7 | 6 | 4 | 5 | 5 | 3 | 4 | 5 | 6 | 42 | 32 |
Min | 57 | 63 | 10 | 12 | 10 | 7 | 5 | 8 | 3 | 5 | 10 | 11 | 188 | 222 |
Max | 179 | 186 | 46 | 56 | 40 | 35 | 32 | 31 | 25 | 26 | 52 | 46 | 352 | 363 |
Values | 751 | 592 | 646 | 510 | 645 | 488 | 57 | 31 | 634 | 481 | 641 | 495 | 89 | 37 |
Historical Profile - Positive Control Values 1999 | ||||||||||||||
Strain | TA100 | TA98 | TA1535 | TA1538 | TA1537 | WP2uvrA | TA102 | |||||||
S9-Mix | -S9 | + S9 | -S9 | + S9 | -S9 | + S9 | -S9 | + S9 | -S9 | + S9 | -S9 | + S9 | -S9 | + S9 |
Mean | 549 | 1019 | 146 | 312 | 368 | 245 | 327 | 446 | 1017 | 345 | 787 | 598 | 882 | 737 |
SD | 176 | 378 | 32 | 129 | 237 | 60 | 157 | 184 | 307 | 152 | 251 | 232 | 186 | 117 |
Min | 238 | 406 | 95 | 113 | 104 | 123 | 113 | 215 | 350 | 112 | 200 | 208 | 583 | 509 |
Max | 1170 | 2060 | 290 | 717 | 1229 | 467 | 653 | 837 | 2031 | 870 | 1760 | 1294 | 1673 | 1261 |
Values | 161 | 160 | 162 | 160 | 158 | 157 | 27 | 27 | 159 | 158 | 153 | 152 | 52 | 51 |
Applicant's summary and conclusion
- Conclusions:
- The test material was considered to be non-mutagenic under the conditions of this test.
- Executive summary:
Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and Escherichia coli strain WP2uvrA were treated with the test material using the Ames plate incorporation method at up to six dose levels, in triplicate, both with and without the addition of a rat liver homogenate metabolising system (10% liver S9 in standard co-factors). This method conforms to the guidelines for bacterial mutagenicity testing published by the major Japanese Regulatory Authorities including MITI, MHW, MOL and MAFF. It also meets the requirement of the OECD Guidelines for Testing of Chemicals No. 471 "Reverse Mutation Study", Method B14 of Commision Directive 92/69/EEC and the USA, EPA (TSCA) OPPTS harmonised guidelines. The dose range for the first experiment was determined in a preliminary toxicity assay and was 1.5 to 500 and 5 to 1500 µg/plate for the Salmonella strains without and with S9 respectively. The dose range for Escherichia coli strain WP2uvrA was 15 to 5000 µg/plate. The experiment was repeated on a separate day using a similar dose range to Experiment 1, fresh cultures of the bacterial strains and fresh test material formulations. Additional dose levels (in excess of the five specified in the standard test method) were employed to allow for the toxicity of the test material and to ensure there were a minimum of four non toxic doses plated out.
The vehicle (dimethyl sulphoxide) control plates gave counts of revertant colonies within the normal range.
All of the positive control chemicals used in the test induced marked increases in the frequency of revertant colonies, both with and with metabolic activation. Thus, the sensitivity of the assay and the efficacy of the S9-mix were validated.
The test material caused both a visible reduction in the growth of the bacterial lawn and/or a significant decrease in the frequency of revertant colonies to all of the tester strains both with and without S9 -mix. The first incidence of a weakened lawn was observed to the Salmonella strains at 500 µg/plate and Escherichia coli strain WP2uvrA at 1500 µg/plate. the test material was, therefore, tested up to the toxic limit. No test material precipitate was observed on the plates at any of the doses tested in either the presence or absence of S9 -mix.
No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test material, either with or without metabolic activation. The test material was considered to be non-mutagenic under the conditions of this test.
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