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EC number: 700-937-1 | CAS number: 1312021-45-6
- 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:
- 11 - 27 March 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The lack of some identifiers of the test substance given in the study report is caused by the status of the test substance at the time of the test period. At that time the test substance was under development with regard to its detailed composition. At a later stage the test substance was identified as UVCB according to REACH regulation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2009
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:
- Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht, Kaiser-Friedrich-Str. 7, 55116 Mainz, Germany
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Fatty acids, C10-12, esters with polylactic acid, sodium salts
- EC Number:
- 700-937-1
- Cas Number:
- 1312021-45-6
- Molecular formula:
- not available
- IUPAC Name:
- Fatty acids, C10-12, esters with polylactic acid, sodium salts
- Test material form:
- liquid: viscous
1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535
- Additional strain / cell type characteristics:
- other: hisG46, uvrB, rfa
- Species / strain / cell type:
- S. typhimurium, other: TA 97a
- Additional strain / cell type characteristics:
- other: his D6610, uvrB, pKM 101, rfa
- Species / strain / cell type:
- S. typhimurium TA 98
- Additional strain / cell type characteristics:
- other: hisD3052, uvrB, pKM 101, rfa
- Species / strain / cell type:
- S. typhimurium TA 100
- Additional strain / cell type characteristics:
- other: hisG46, uvrB, pKM101, rfa
- Species / strain / cell type:
- S. typhimurium TA 102
- Additional strain / cell type characteristics:
- other: hisG428, pKM101, rfa
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- First experiment (plate incorporation method): 502, 151, 50, 15, 15, 5, 1.5 µg/plate
Second experiment (pre-incubation method): 498, 149, 50, 15, 5 µg/plate - Vehicle / solvent:
- - Solvent used: DMSO
- Justification for choice of solvent:
DMSO was chosen as solvent, because the test item was completely soluble, and this solvent does not have any effects on the viability of the bacteria or the number of spontaneous revertants. For solution of the test item the stock solution was used. Each solution was membrane filtrated to accomplish sterility.
Controls
- Untreated negative controls:
- yes
- Remarks:
- Water
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- benzo(a)pyrene
- other: 4-Nitro-o-phenylenediamine; 2-Aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
First experiment: in agar (plate incorporation)
Second experiment: preincubation method
DURATION
- Preincubation period: 10 h at 37 °C
- Exposure duration: 48 h at 37 °C
- Expression time (cells in growth medium): Befor estarting the experiment cell titre should give a density of 10 9 cells/mL at the least.
SELECTION AGENT (mutation assays): Depending on deficinecy of the individual strain used: ampicillin or ampicillin in combination with tetracyclin were added. TA 1535 was incubated without addition of antibiotica
NUMBER OF REPLICATIONS: Per strain and dose four strains with and four plates without S9 mix were used.
DETERMINATION OF CYTOTOXICITY
- Method: Cytotoxicity control was performed by adding 500, 1500 and 500 µg/plate of the test item to the overnight culture diluted in sodium chloride solution with and without S9 on maximal soft agar. Normal growth was observed at a concentration not exceeding 500 µg/plat. Therefor this concentration was chosen as highest concentration in the test.
CONTROL TESTS TO CONFIRM COMPLIANCE OF THE RESULTS OBTAINED IN THE STUDY
- Genotype Confirmation. Genotype confirmation is performed once a term.
- Histidine requiremen: Each strain was streaked on a biotin and a histidine-biotin-plate, using a sterilized wire loop.
- Ampicillin-Resistance (pKM 101) resp. ampicillin-tetracycline-resistance (pAQ1): The strains were streaked on ampicillin agar, TA102 on ampicillin-tetracycline agar. TA1535 was taking the function of control strain, since it is not ampicillin resistant.
- UV-sensitivity (uvrB): Two plates were streaked with the five strains, and one half of the plate covered with aluminium foil so that one half of each streak was protected against light. The plates were irradiated for 8 seconds with a germicidal lamp (254 nm, 30W), keeping a distance of 33 cm. Incubation over night at 37 °C followed.
- Crystal violet sensitivity (deep rough): For each strain, two plates were used. 0.1 mL of bacteria suspension were mixed with 2 mL Top-Agar and poured on nutrient agar. Sterile paper discs (Æ9 mm), each soaked with 10 µl of crystal violet solution (0.1%) were placed into the middle of each plate, followed by incubation over night.
- Spontaneous revertants: Four replicates, with/without S9, for each solvent which was used in the test.
- Determination of Titre: The titre was determined by dilution of the overnight culture using sodium chloride solution and placing 0.1 mL on maximal-soft agar. It should give a density of 109cells/mL (at the least).
- Toxicity Control: Performed analogously to the titre control with the maximum dose of test item with and without S9 on maximal-soft agar.
- Sterility Control: Performed analogously to the test with solvent only and S9 (without adding bacteria) on top agar.
- Positive Controls: Using diagnostic mutagens, four replicates were prepared. The stock solutions of the substances were diluted to effect an application volume of 0.1 mL/plate.
Without metabolic activation system
4-Nitro-1,2-phenylene diamine Concentration per plate: 80 µg; strains 97a, 98 and 102.
Sodium azide Concentration per plate: 6 µg; strains 100 and 1535.
With metabolic activation system
Benzo(a)pyrene Concentration per plate: 40 µg; strain 98.
2-Aminoanthracene (2-AA) Concentration per plate: 3 µg; strains 97a, 100, 102 and 1535. - Evaluation criteria:
- A test item can be considered to have mutagneic potential, if a significant, reproducible increase of revertant colonies per plate (increase factor > = 2) in at least one strain can be observed. A concentration - related increase over the range tested can also be taken as a sign of mutagenetic activity.
- Statistics:
- The colonies were counted visually, the numbers were recorded. A spreadsheet software (microsoft excel) was used to calculate mean values and standard deviations as well as the increase factor of revertant induction.
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 nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- Exp. 2 highest concentration
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium, other: TA 97a
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- Exp. 2 highest concentration
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- 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 nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- Exp. 2 highest concentration
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- 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 nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- Exp. 2 highest concentration
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- Exp. 2 highest concentration
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES: see result on cytotoxicity test
COMPARISON WITH HISTORICAL CONTROL DATA:
In the following table, the mean of the spontaneous revertants and positive controls of all performed experiments in the year 2009 is stated (Number of experiments: 3) in compari-son with the experiments performed within this study.
Strain TA97a TA98 TA100 TA102 TA1535
Induction - S9 + S9 - S9 + S9 - S9 + S9 - S9 + S9 - S9 + S9
H2O Mean 105 105 7 8 119 112 215 225 11 13
Min 92 99 6 7 107 100 165 205 8 10
Max 124 109 9 10 130 122 261 237 14 16
Exp 1 92 108 6 10 120 113 220 237 8 10
Exp 2 124 109 9 7 107 100 165 205 14 14
DMSO Mean 123 95 7 8 121 123 247 223 10 11
Min 106 86 6 5 111 115 219 162 8 9
Max 133 108 8 10 138 131 269 253 13 13
Exp 1 133 86 6 8 111 115 219 253 8 12
Exp 2 129 90 7 10 115 131 269 162 9 9
Pos. Contr. Mean 1001 1001 1001 1001 1001 1001 1001 1001 1001 1001
Min 1001 1001 1001 1001 1001 1001 1001 1001 1001 1001
Max 1001 1001 1001 1001 1001 1001 1001 1001 1001 1001
Exp 1 1001 1001 1001 1001 1001 1001 1001 1001 1001 1001
Exp 2 1001 1001 1001 1001 1001 1001 1001 1001 1001 1001
In this table, “> 1000” is represented by “1001”.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
The toxicity of the following concentrations were tested: 5005, 1502 and 501 µg/plate.
Per strain, four plates were incubated with the corresponding dose of the test item on maximal soft agar.
16.1 Experimental Parameters
Date of treatment 11. March 2009
Concentrations tested 5005 / 1502 / 501µg/plate
Incubation time 48 hours
Incubation temperature 37 °C
Tester strains TA97a, TA98, TA100, TA102, TA1535
Method Plate incorporation method
In the two higher concentrations (5003 and 1502 µg/plate), the test item showed cytotoxic-ity towards all the strains. In the lower concentration (501 µg/plate), normal growth oc-curred.
On the base of these results, the first experiment was performed with 500 µg/plate as maximum dose for all strains.
Any other information on results incl. tables
Table 1: Mean revertants Experiment 1
Strain |
TA97a |
TA98 |
TA100 |
TA102 |
TA1535 |
||||||
Induction |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
H20 |
Mean |
92 |
108 |
6 |
10 |
120 |
113 |
220 |
237 |
8 |
10 |
sd |
32.0 |
23.5 |
1.7 |
3.8 |
7.2 |
4.4 |
46.5 |
43.4 |
3.7 |
2.4 |
|
DMSO |
Mean |
133 |
86 |
6 |
8 |
111 |
115 |
219 |
253 |
8 |
12 |
sd |
31.7 |
27.0 |
1.0 |
3.2 |
14.5 |
26.3 |
22.2 |
19.1 |
2.4 |
2.4 |
|
Pos.Contr. |
Mean |
1001 |
1001 |
1001 |
1001 |
1001 |
1001 |
1001 |
1001 |
1001 |
1001 |
sd |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
f(I) |
7.53 |
11.64 |
166.8 |
125.1 |
8.34 |
8.70 |
4.57 |
3.96 |
125.1 |
83.42 |
|
501 µg/pl. |
Mean |
107 |
100 |
6 |
7 |
139 |
133 |
206 |
220 |
6 |
9 |
sd |
7 |
25 |
3 |
4 |
9 |
23 |
4 |
9 |
4 |
2 |
|
f(I) |
0.80 |
1.16 |
1.00 |
0.88 |
1.25 |
1.16 |
0.94 |
0.87 |
0.75 |
0.75 |
|
151 µg/pl. |
Mean |
124 |
99 |
8 |
7 |
92 |
105 |
292 |
252 |
11 |
10 |
sd |
17 |
19 |
3 |
2 |
23 |
41 |
21 |
71 |
1 |
2 |
|
f(I) |
0.93 |
1.15 |
1.33 |
0.88 |
0.83 |
0.91 |
1.33 |
1.00 |
1.38 |
0.83 |
|
50 µg/pl. |
Mean |
80 |
112 |
7 |
5 |
111 |
102 |
250 |
257 |
9 |
5 |
sd |
28 |
36 |
1 |
1 |
13 |
11 |
99 |
53 |
2 |
2 |
|
f(I) |
0.60 |
1.30 |
1.17 |
0.63 |
1.00 |
0.89 |
1.14 |
1.02 |
1.13 |
0.42 |
|
15 µg/pl. |
Mean |
112 |
109 |
9 |
9 |
101 |
94 |
213 |
200 |
13 |
10 |
sd |
32 |
34 |
1 |
2 |
14 |
22 |
16 |
35 |
3 |
4 |
|
f(I) |
0.84 |
1.27 |
1.50 |
1.13 |
0.91 |
0.82 |
0.97 |
0.79 |
1.63 |
0.83 |
|
5 µg/pl. |
Mean |
114 |
112 |
8 |
9 |
89 |
98 |
201 |
189 |
7 |
11 |
sd |
19 |
37 |
2 |
2 |
24 |
13 |
27 |
26 |
4 |
2 |
|
f(I) |
0.86 |
1.30 |
1.33 |
1.13 |
0.80 |
0.85 |
0.92 |
0.75 |
0.88 |
0.92 |
|
1.5 µg/pl. |
Mean |
97 |
103 |
8 |
6 |
119 |
92 |
244 |
243 |
9 |
12 |
sd |
29 |
41 |
2 |
1 |
12 |
5 |
62 |
81 |
5 |
4 |
|
f(I) |
0.73 |
1.20 |
1.33 |
0.75 |
1.07 |
0.80 |
1.11 |
0.96 |
1.13 |
1.00 |
In this table, "> 1OOO" is represented by "1001". Induction factors for the respective treatments are stated as lower limit.
Table 2: Mean revertants Experiment 2
Strain |
TA97a |
TA98 |
TA100 |
TA102 |
TA1535 |
||||||||||
Induction |
|
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
||||
H20 |
|
Mean |
99 |
108 |
10 |
9 |
122 |
130 |
220 |
232 |
11 |
13 |
|||
sd |
9.8 |
10.7 |
3.1 |
3.5 |
13.4 |
15.2 |
8.3 |
8.2 |
1.7 |
2.9 |
|||||
DMSO |
Mean |
103 |
100 |
8 |
10 |
117 |
117 |
237 |
265 |
13 |
14 |
||||
sd |
11.5 |
10.5 |
1.5 |
1.3 |
12.6 |
12.5 |
25.7 |
14.7 |
3.2 |
2.6 |
|||||
Pos.Contr. |
Mean |
1001 |
1001 |
1001 |
1001 |
1001 |
1001 |
1001 |
1001 |
1001 |
1001 |
||||
sd |
0 |
0 |
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
f(I) |
9.72 |
10.01 |
125.1 |
100.1 |
8.20 |
8.56 |
4.22 |
3.78 |
91.00 |
71.50 |
|||||
498 µg/pl. |
Mean |
|
15 |
12 |
7 |
5 |
20 |
51 |
16 |
24 |
3 |
10 |
|||
sd |
15 |
7 |
3 |
4 |
10 |
5 |
4 |
5 |
1 |
2 |
|||||
f(I) |
0.15 |
0.12 |
0.88 |
0.50 |
0.17 |
0.44 |
0.07 |
0.09 |
0.23 |
0.71 |
|||||
149 µg/pl. |
Mean |
129 |
112 |
9 |
5 |
119 |
121 |
256 |
228 |
10 |
11 |
||||
sd |
26 |
9 |
1 |
1 |
24 |
49 |
40 |
27 |
4 |
1 |
|||||
f(I) |
1.25 |
1.12 |
1.13 |
0.50 |
1.02 |
1.03 |
1.08 |
0.86 |
0.77 |
0.79 |
|||||
50 µg/pl. |
|
Mean |
90 |
109 |
7 |
7 |
103 |
69 |
236 |
150 |
11 |
10 |
|||
sd |
15 |
6 |
4 |
5 |
12 |
6 |
27 |
17 |
2 |
2 |
|||||
f(I) |
0.87 |
1.09 |
0.88 |
0.70 |
0.88 |
0.59 |
1.00 |
0.57 |
0.85 |
0.71 |
|||||
15 µg/pl. |
Mean |
137 |
113 |
9 |
5 |
93 |
98 |
151 |
186 |
8 |
8 |
||||
sd |
7 |
23 |
1 |
2 |
21 |
15 |
13 |
28 |
2 |
2 |
|||||
f(I) |
1.33 |
1.13 |
1.13 |
0.50 |
0.79 |
0.84 |
0.64 |
0.70 |
0.62 |
0.57 |
|||||
5 µg/pl. |
Mean |
126 |
135 |
10 |
9 |
89 |
94 |
147 |
187 |
7 |
9 |
||||
sd |
23 |
14 |
3 |
3 |
9 |
14 |
14 |
52 |
2 |
5 |
|||||
f(I) |
1.22 |
1.35 |
1.25 |
0.90 |
0.76 |
0.80 |
0.62 |
0.71 |
0.54 |
0.64 |
In this table, "> 1OOO" is represented by "1001". Induction factors for the respective treatments are stated as lower limit.
Table 3: Historical control data
Strain |
|
TA97a |
TA98 |
TA100 |
TA102 |
TA1535 |
|||||||
Induction |
|
|
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
H20 |
Mean |
105 |
105 |
7 |
8 |
119 |
112 |
215 |
225 |
11 |
13 |
||
Min |
92 |
99 |
6 |
7 |
107 |
100 |
|
165 |
205 |
8 |
10 |
||
Max |
124 |
109 |
9 |
10 |
130 |
122 |
261 |
237 |
14 |
16 |
|||
Exo 1 |
92 |
108 |
6 |
10 |
120 |
113 |
220 |
237 |
8 |
10 |
|||
Exp 2 |
124 |
109 |
9 |
7 |
107 |
100 |
165 |
205 |
14 |
14 |
|||
DMSO |
Mean |
123 |
95 |
7 |
8 |
121 |
123 |
247 |
223 |
10 |
11 |
||
Min |
106 |
86 |
6 |
5 |
111 |
115 |
219 |
162 |
8 |
9 |
|||
Max |
133 |
108 |
8 |
10 |
138 |
131 |
269 |
253 |
13 |
13 |
|||
Exo 1 |
133 |
86 |
6 |
8 |
111 |
115 |
219 |
253 |
8 |
12 |
|||
Exo 2 |
129 |
90 |
7 |
10 |
115 |
131 |
269 |
162 |
9 |
9 |
|||
|
Mean |
1001 |
1001 |
1001 |
1001 |
1001 |
1001 |
1001 |
1001 |
1001 |
1001 |
||
Pos. Contr. |
Min |
1001 |
1001 |
1001 |
1001 |
1001 |
1001 |
1001 |
1001 |
1001 |
1001 |
||
Max |
1001 |
1001 |
1001 |
1001 |
1001 |
1001 |
1001 |
1001 |
1001 |
1001 |
|||
Exp 1 |
1001 |
1001 |
1001 |
1001 |
1001 |
1001 |
1001 |
1001 |
1001 |
1001 |
|||
Exo 2 |
1001 |
1001 |
1001 |
1001 |
1001 |
1001 |
1001 |
1001 |
1001 |
1001 |
In this table, "> 1OOO" is represented by "1001".
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
- Executive summary:
The test item did not show mutagenic effects in both experiments. The number of revertant colonies was not increased in comparison with the spontaneous revertants (solvent only). Cytotoxicity of the test item was detected in the second experiment in the highest concentration 498 µg/plate. The background lawn was visible but the number of revertants was decreased. In the lower concentrations, normal growth occurred.
The test item is considered not mutagenic for the reasons given above.
In the cytotoxicity experiment, the test item showed cytotoxicity towards the bacteria in the follow concentrations: 5000 µg/plate and 1500 µg/plate; on the base of these results the highest concentration in the first experiment was chosen with 500 µg/plate. The test item showed any cytotoxicity towards the bacteria in the second experiment (using the pre-incubation method) in the highest concentration (500 µg/plate). The lower concentrations showed normal growth.
The confirmation tests of the genotype did not show any irregularities. The control of the titre was above the demanded value. The number of revertant colonies of the positive controls was in the range of the historical data of the laboratory and the revertants were increased in comparison with the negative controls, as well as showing mutagenous potential of the diagnostic mutagenes. Some of the spontaneous revertants are lower than the values given by Prof. Ames; in comparison with the historical data of the LAUS GmbH, they were within the normal range. For these reasons, the result of the test is considered valid.
Therefore it can be stated, that under the test conditions, the test item is not mutagenic in the Bacterial Reverse Mutation Test using Salmonella typhimurium, strains TA 97a, TA 98, TA 100, TA 102 and TA 1535.
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