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EC number: 700-414-8 | CAS number: 23328-71-4
- 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:
- Between 31 July 2007 and 27 August 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
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)
- Remarks:
- Date of inspection: 30 August 2005 Date of Signature: 21 November 2005
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- trimethyl[3-(octadecyloxy)propyl]azanium chloride
- EC Number:
- 700-414-8
- Cas Number:
- 23328-71-4
- Molecular formula:
- C24H52ClNO
- IUPAC Name:
- trimethyl[3-(octadecyloxy)propyl]azanium chloride
- Reference substance name:
- 1-Propanaminium, N,N,N-trimethyl-3-(octadecyloxy)-, chloride
- IUPAC Name:
- 1-Propanaminium, N,N,N-trimethyl-3-(octadecyloxy)-, chloride
- Details on test material:
- - Name of test material (as cited in study report): 3-Octadecyloxypropyl-N,N,N-trimethylammonium chloride
- Molecular formula (if other than submission substance): Not applicable
- Molecular weight (if other than submission substance): Not applicable
- Smiles notation (if other than submission substance): Not applicable
- InChl (if other than submission substance): Not applicable
- Structural formula attached as image file (if other than submission substance): Not applicable
- Substance type: white solid
- Physical state: solid
- Analytical purity: Not reported
- Impurities (identity and concentrations): Not reported
- Composition of test material, percentage of components: Not reported
- Isomers composition: Not reported
- Purity test date: Not reported
- Lot/batch No.: Exp. I-070518
- Expiration date of the lot/batch: Not reported
- Radiochemical purity (if radiolabelling): Not applicable
- Specific activity (if radiolabelling): Not applicable
- Locations of the label (if radiolabelling): Not applicable
- Expiration date of radiochemical substance (if radiolabelling): Not applicable
- Stability under test conditions: Not reported.
- Storage condition of test material: room temperature in the dark
- Other: Not reported.
Constituent 1
Constituent 2
Method
- Target gene:
- Histidine encoding gene (his) for Salmonella.
Tryptophan encoding gene (trp) for E.Coli.
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):
- Not applicable.
- Additional strain / cell type characteristics:
- other: Including a deletion through the excision repair gene (uvrB-) which renders the capability of DNA exision repair and deep rough mutation (rfa)
- Species / strain / cell type:
- E. coli WP2 uvr A
- Details on mammalian cell type (if applicable):
- Not applicable.
- Additional strain / cell type characteristics:
- other: Including a deletion through the excision repair gene (uvrA-)
- Metabolic activation:
- with and without
- Metabolic activation system:
- phenobarbitone/betanaphthoflavone induced rat liver, S9
- 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
Range-finding Test: 0, 0.5, 1.5, 5, 15, 50, 150, 500, 1500 and 5000 µg/plate
Main Test: 0, 0.5, 1.5, 5, 15, 50, 150, 500, 1500 and 5000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Sterile distilled water.
- Justification for choice of solvent/vehicle: The test material was fully soluble in sterile distilled water at 50 mg/ml in solubility checks performed in-house.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- concurrent untreated control
- Negative solvent / vehicle controls:
- yes
- Remarks:
- sterile distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- With S9 mix
- Untreated negative controls:
- yes
- Remarks:
- concurrent untreated control
- Negative solvent / vehicle controls:
- yes
- Remarks:
- sterile distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- With S9 mix
- Untreated negative controls:
- yes
- Remarks:
- concurrent untreated control
- Negative solvent / vehicle controls:
- yes
- Remarks:
- sterile distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- without S9 mix
Migrated to IUCLID6: 4-nitroquinoline-1-oxide
- Untreated negative controls:
- yes
- Remarks:
- concurrent untreated control
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Sterile distilled water.
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without S9 mix
- Untreated negative controls:
- yes
- Remarks:
- concurrent untreated control
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Sterile distilled water.
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- without S9 mix
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: 10h
- Exposure duration: 48 hrs
- Expression time (cells in growth medium): Not applicable
- Selection time (if incubation with a selection agent): Not applicable
- Fixation time (start of exposure up to fixation or harvest of cells): 48 hrs
SELECTION AGENT (mutation assays): Not applicable.
NUMBER OF REPLICATIONS: Triplicate plating.
NUMBER OF CELLS EVALUATED: Not applicable.
DETERMINATION OF CYTOTOXICITY: Plates were assessed for numbers of revertant colonies and examined for effects on the growth of the bacterial background lawn.
OTHER EXAMINATIONS
- Other:
Solubility: Test material precipitation was examined on the plates.
Sterlility: (Preliminary study only) The aliquot of 0.1 ml of maximum concentration of the test material (5000 µg/plate) and 2 ml of molten, trace histidine or tryptophan supplemented, top agar were overlaid onto a sterile Nutrient agar plate in order to assess the sterility of the test material.
- Evaluation criteria:
- There are several criteria for determining a positive result, such as a dose-related increase in revertant frequency over the dose range tested and/or a reproducible increase at one or more concentrations in at least one bacterial strain with or without metabolic activation. Biological relevance of the results will be considered first, statistical methods, as recommended by the UKEMS can also be used as an aid to evaluation, however, statistical significance will not be the only determining factor for a positive response.
A test material will be considered non-mutagenic (negative) in the test system if the above criteria are not met.
Although most experiments will give clear positive or negative results, in some instances the data generated will prohibit a definitive judgement about the test material activity. Results of this type will be reported as equivocal. - Statistics:
- UKEMS
Results and discussion
Test resultsopen allclose all
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- tested up to maximum recommended dose of 5000 micro.g/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- 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 nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- tested up to maximum recommended dose of 5000 micro.g/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: The test material was fully soluble in sterile distilled water at 50 mg/ml in solubility checks performed in–house.
- Precipitation: No test material precipitate was observed on the plates at any of the doses tested in either the presence or absence of S9-mix.
RANGE-FINDING/SCREENING STUDIES:
Preliminary Toxicity Test:
The test material was toxic initially at 150 µg/plate and 500 µg/plate to TA100 and WP2uvrA- respectively (Table 1 below). The test material formulation and S9-mix used in this experiment were both shown to be sterile.
COMPARISON WITH HISTORICAL CONTROL DATA:
Prior to use, the master strains were checked for characteristics, viability and spontaneous reversion rate (all were found to be satisfactory). The amino acid supplemented top agar and the S9-mix used in both experiments was shown to be sterile.
Results for the negative controls (spontaneous mutation rates) were considered to be acceptable.
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.
ADDITIONAL INFORMATION ON CYTOTOXICITY: The test material caused a visible reduction in the growth of the bacterial background lawns to all of the strains initially at 50 µg/plate (Table 2 to 4 below and Table 5 attached). - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
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 |
70 |
74 |
75 |
76 |
86 |
80 |
80 |
0* |
0* |
0* |
0* |
+ |
TA100 |
77 |
87 |
84 |
87 |
73 |
62 |
62 |
37 |
0* |
0* |
0* |
- |
WP2uvrA- |
24 |
30 |
28 |
20 |
32 |
18 |
31 |
21 |
22* |
9* |
0* |
+ |
WP2uvrA- |
30 |
34 |
36 |
37 |
34 |
24 |
29 |
23 |
18 |
23* |
0* |
* Partial or total absence of bacterial background lawn.
Table 2 Test Results: Range-Finding Test– Without Metabolic Activation
Test Period |
From:09 August 2007 |
To: 12 August 2007 |
||||||||||
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 |
113 98 97 |
(103) 9.0# |
13 28 9 |
(17) 10.0 |
24 24 23 |
(24) 0.6 |
18 16 13 |
(16) 2.5 |
15 2 5 |
(7) 6.8 |
|
|
0.5 |
105 98 108 |
(104) 5.1 |
16 15 15 |
(15) 0.6 |
N/T |
10 10 17 |
(12) 4.0 |
5 3 6 |
(5) 1.5 |
||
|
1.5 |
112 112 107 |
(110) 2.9 |
16 20 19 |
(18) 2.1 |
N/T |
20 15 18 |
(18) 2.5 |
14 7 7 |
(9) 4.0 |
||
- |
5 |
97 105 95 |
(99) 5.3 |
23 13 21 |
(19) 5.3 |
27 23 22 |
(24) 2.6 |
9 15 11 |
(12) 3.1 |
9 8 9 |
(9) 0.6 |
|
- |
15 |
95 100 126 |
(107) 16.6 |
18 25 20 |
(21) 3.6 |
19 21 15 |
(18) 3.1 |
20 14 15 |
(16) 3.2 |
2 16 8 |
(9) 7.0 |
|
- |
50 |
74 * 72 * 75 * |
(74) 1.5 |
10 * 6 * 7 * |
(8) 2.1 |
23 23 22 |
(23) 0.6 |
11 9 11 |
(10) 1.2 |
3 * 3 * 4 * |
(3) 0.6 |
|
- |
150 |
0 * 0 * 0 * |
(0) 0.0 |
0 * 0 * 0 * |
(0) 0.0 |
14 16 11 |
(14) 2.5 |
0 * 0 * 0 * |
(0) 0.0 |
0 * 0 * 0 * |
(0) 0.0 |
|
- |
500 |
0 * 0 * 0 * |
(0) 0.0 |
0 * 0 * 0 * |
(0) 0.0 |
22 19 15 |
(19) 3.5 |
0 * 0 * 0 * |
(0) 0.0 |
0 * 0 * 0 * |
(0) 0.0 |
|
- |
1500 |
N/T |
N/T |
8 * 6 * 6 * |
(7) 1.2 |
N/T |
N/T |
|||||
- |
5000 |
N/T |
N/T |
0 * 0 * 0 * |
(0) 0.0 |
N/T |
N/T |
|||||
Positive controls S9-Mix - |
Name Concentration (μg/plate) No. colonies per plate |
ENNG |
ENNG |
ENNG |
4NQO |
9AA |
||||||
3 |
5 |
2 |
0.2 |
80 |
||||||||
457 449 445 |
(450) 6.1 |
272 259 274 |
(268) 8.1 |
427 456 404 |
(429) 26.1 |
97 100 92 |
(96) 4.0 |
2033 1887 2043 |
(1988) 87.3 |
Table 3 Test Results: Range-Finding Test– With Metabolic Activation
Test Period |
From:09 August 2007 |
To: 12 August 2007 |
||||||||||
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 |
112 103 100 |
(105) 6.2# |
8 7 11 |
(9) 2.1 |
28 34 21 |
(28) 6.5 |
21 14 27 |
(21) 6.5 |
11 2 8 |
(7) 4.6 |
|
+ |
0.5 |
103 90 91 |
(95) 7.2 |
7 7 5 |
(6) 1.2 |
N/T |
14 13 32 |
(20) 10.7 |
3 7 2 |
(4) 2.6 |
||
+ |
1.5 |
99 104 103 |
(102) 2.6 |
13 13 9 |
(12) 2.3 |
N/T |
21 19 24 |
(21) 2.5 |
4 5 11 |
(7) 3.8 |
||
+ |
5 |
98 97 92 |
(96) 3.2 |
7 5 7 |
(6) 1.2 |
32 19 25 |
(25) 6.5 |
23 21 15 |
(20) 4.2 |
8 6 4 |
(6) 2.0 |
|
+ |
15 |
91 102 90 |
(94) 6.7 |
5 5 4 |
(5) 0.6 |
13 26 15 |
(18) 7.0 |
15 14 20 |
(16) 3.2 |
11 15 5 |
(10) 5.0 |
|
+ |
50 |
75 87 90 |
(84) 7.9 |
5 10 5 |
(7) 2.9 |
25 21 21 |
(22) 2.3 |
20 18 16 |
(18) 2.0 |
4 7 6 |
(6) 1.5 |
|
+ |
150 |
61 54 65 |
(60) 5.6 |
0 * 0 * 0 * |
(0) 0.0 |
27 21 23 |
(24) 3.1 |
19 19 8 |
(15) 6.4 |
4 * 1 * 3 * |
(3) 1.5 |
|
+ |
500 |
0 * 0 * 0 * |
(0) 0.0 |
0 * 0 * 0 * |
(0) 0.0 |
15 20 11 |
(15) 4.5 |
0 * 0 * 0 * |
(0) 0.0 |
0 * 0 * 0 * |
(0) 0.0 |
|
+ |
1500 |
N/T |
N/T |
14 * 9 * 8 * |
(10) 3.2 |
N/T |
N/T |
|||||
+ |
5000 |
N/T |
N/T |
0 * 0 * 0 * |
(0) 0.0 |
N/T |
N/T |
|||||
Positive controls S9-Mix + |
Name Concentration (μg/plate) No. colonies per plate |
2AA |
2AA |
2AA |
BP |
2AA |
||||||
1 |
2 |
10 |
5 |
2 |
||||||||
1159 1102 1069 |
(1110) 45.5 |
190 196 195 |
(194) 3.2 |
206 134 359 |
(233) 114.9 |
278 278 337 |
(298) 34.1 |
387 329 236 |
(317) 76.2 |
Table 4 Results: Main Test– Without Metabolic Activation
Test Period |
From: 20 August 2007 From:24 August 2007† |
To: 23 August 2007 To: 27 August 2007† |
||||||||||
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 |
98 103 91 |
(97) 6.0# |
8 10 10 |
(9) 1.2 |
24 23 22 |
(23) 1.0 |
11 10 12 |
(11) 1.0 |
9 12 11 |
(11) 1.5 |
|
- |
0.5 |
92 107 85 |
(95) 11.2 |
3 19 4 |
(9) 9.0 |
N/T |
10 12 9 |
(10) 1.5 |
12 25 18 |
(18) 6.5 |
||
- |
1.5 |
93 92 93 |
(93) 0.6 |
5 5 9 |
(6) 2.3 |
N/T |
12 11 12 |
(12) 0.6 |
16 11 10 |
(12) 3.2 |
||
- |
5 |
96 88 90 |
(91) 4.2 |
2 4 7 |
(4) 2.5 |
25 21 19 |
(22) 3.1 |
9 18 13 |
(13) 4.5 |
16 11 23 |
(17) 6.0 |
|
- |
15 |
102 81 102 |
(95) 12.1 |
3 1 7 |
(4) 3.1 |
16 31 22 |
(23) 7.5 |
16 7 15 |
(13) 4.9 |
8 21 12 |
(14) 6.7 |
|
- |
50 |
86 84 77 |
(82) 4.7 |
7 2 4 |
(4) 2.5 |
22 24 15 |
(20) 4.7 |
10 12 8 |
(10) 2.0 |
0 * 0 * 0 * |
(0) 0.0 |
|
- |
150 |
0 * 0 * 0 * |
(0) 0.0 |
1 * 4 * 8 * |
(4) 3.5 |
15 27 22 |
(21) 6.0 |
0 * 0 * 0 * |
(0) 0.0 |
0 * 0 * 0 * |
(0) 0.0 |
|
- |
500 |
0 * 0 * 0 * |
(0) 0.0 |
0 * 0 * 0 * |
(0) 0.0 |
13 14 14 |
(14) 0.6 |
0 * 0 * 0 * |
(0) 0.0 |
0 * 0 * 0 * |
(0) 0.0 |
|
- |
1500 |
N/T |
N/T |
15 * 8 * 13 * |
(12) 3.6 |
N/T |
N/T |
|||||
- |
5000 |
N/T |
N/T |
0 * 0 * 0 * |
(0) 0.0 |
N/T |
N/T |
|||||
Positive controls S9-Mix - |
Name Concentration (μg/plate) No. colonies per plate |
ENNG |
ENNG |
ENNG |
4NQO |
9AA |
||||||
3 |
5 |
2 |
0.2 |
80 |
||||||||
429 438 415 |
(427) 11.6 |
231 264 331 |
(275) 51.0 |
236 240 239 |
(238) 2.1 |
134 141 114 |
(130) 14.0 |
589 1111 841 |
(847) 261.1 |
|||
ENNG N-ethyl-N'-nitro-N-nitrosoguanidine
4NQO 4-Nitroquinoline-1-oxide
9AA 9-Aminoacridine
N/T Not tested at this dose level
* Partial or total absence of bacterial background lawn
† Experimental procedure repeated at a later date due to excessive contamination (TA100) and toxicity (WP2uvrA-)
# Standard deviation
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The test material was considered to be non-mutagenic under the conditions of this test. - Executive summary:
Introduction. The method was designed to conform to the guidelines for bacterial mutagenicity testing published by the major Japanese Regulatory Authorities including METI, MHLW and MAFF. It also meets the requirements of the OECD Guidelines for Testing of Chemicals No. 471 "Bacterial Reverse Mutation Test", Method B13/14 of Commission Directive 2000/32/EC and the, EPA (TSCA) OPPTS harmonised guidelines.
Methods. Salmonella typhimurium strains TA1535, TA1537, TA98 and TA100 and Escherichia coli strain WP2uvrA- were treated with solutions of the test material using the Ames plate incorporation method at seven dose levels, in triplicate, both with and without the addition of a rat liver homogenate metabolising system (10% liver S9 in standard co-factors). The dose range for the range-finding test was determined in a preliminary toxicity assay and ranged between 0.5 and 5000 µg/plate depending on strain type. The experiment was repeated on a separate day using the same dose range as the range-finding test, fresh cultures of the bacterial strains and fresh test material formulations.
Additional dose levels (0.5, 1.5, 5 and 15 µg/plate) were included to allow for test material induced toxicity, ensuring that at least four non-toxic doses were achieved.
Results. The vehicle (sterile distilled water) 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 or without metabolic activation. Thus, the sensitivity of the assay and the efficacy of the S9-mix were validated.
The test material caused a visible reduction in the growth of the bacterial background lawns to all of the strains initially at 50 µg/plate. The test material was, therefore, either tested up to the maximum recommended dose level or its toxic limit, depending on strain type. 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.
Conclusion. The test material was considered to be non-mutagenic under the conditions of this test.
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