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EC number: 246-885-9 | CAS number: 25354-97-6
- 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:
- March - April 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP compliant
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- from July 21, 1997
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Certificate of Compliance with Good Laboratory Practices according to Directives 2004/9/CE and 2004/10/CE, Groupe Interministeriel des Produits Chimiques, Republique Francaise, Certificat n°: 2016/48, dated 2 Nov 2016
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-hexyldecanoic acid
- EC Number:
- 246-885-9
- EC Name:
- 2-hexyldecanoic acid
- Cas Number:
- 25354-97-6
- Molecular formula:
- C16H32O2
- IUPAC Name:
- 2-hexyldecanoic acid
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: delivered from Sponsor, BATCH: 05297/MA
- Expiration date of the lot/batch: October 2021
- Purity test date: 27.10.2017
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature (15 - 25°C), non hygroscopic
- Stability: stable under storage conditions
- Solubility and stability of the test substance in the solvent/vehicle: soluble in DMSO, test solutions used immediately after preparation, no further details mentioned
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: no data
Method
- Target gene:
- his D, his C, his G, tryp E
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Remarks:
- E. coli uvrA-
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 microsome fraction prepared from Sprague Dawley rat liver homogenate, was provided by MOLTOXTM (POB Box 1189 - 157 Industrial Park Dr - Boone, NC 28607 - USA) (S9 Moltox-11101-5-3919 validated on 28.06.2018 – expiry date: 07.02.2020).
- Test concentrations with justification for top dose:
- 50, 150, 500, 1500 and 5000 µg/plate with and without S9 mix, top dose chosen according to guideline
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: test item is soluble in DMSO
Controls
- Untreated negative controls:
- yes
- Remarks:
- absolute negative control containing no test item; negative controls with solvents used to solubilize positive controls (Acetone, DMSO, NaCl 0.15 M)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- vehicle used to solubilize test item (DMSO)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 7,12-dimethylbenzanthracene
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- other: cis-Platinum (II) Diammine Dichloride, CAS 15663-27-1: 1 µg/plate, E. coli without S9; 2-anthramine, CAS 613-13-8: 2 µg/plate, TA 98, 100, 1535, 1537 with S9 (plate incorporation); 1 µg/plate, TA 98, 100, 1535, 1537, with S9 (pre-incubation)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
Salmonella Typhimurium strains: for each strain, 0.1 mL of the bacterial suspension containing 1-9 x10exp9 bacteria/mL) and 0.1 mL (in -aqueous or -oily vehicle / 50 µL (in non-aqueous or non-oily vehicle as ethanol ….) of each dilution of the original solution and 0.5 mL of sterile phosphate buffer were successively added to 2 mL of overlay agar, maintained supercooled at 45° C, containing 10 % (v/v) of a L-Histidine-D-Biotine solution (0.5 mM).
Escherichia coli strain : in a test tube 0.1 mL of the bacterial suspension containing 1-9 x 10exp9 bacteria/mL and ) and 0.1 mL (in -aqueous or -oily vehicle / 50 µL (in non-aqueous or non-oily vehicle as ethanol ….) of each dilution of the original solution and 0.5 mL of phosphate buffer were successively added to 2 mL of overlay agar maintained super cooled in 45° C containing 5% (v/v) of nutrient broth n° 2 to which are added 5 µL of a L-Tryptophane solution at 2 mg/mL.
Plates were incubated at 37° C over a 48-72-hour period. The number of revertant colonies per plate was counted.
Moreover the following controls were carried out:
Negative controls :
o absolute negative control containing no test item corresponding to the spontaneous reversion rate,
o solvent used to solubilize positive controls : Acetone, DMSO, NaCl 0.15 M
Vehicle used to solubilize test item : DMSO
Positive control
Two methodologies can be used: - either a standard plate incorporation method where the protocol is similar to that described above, except that, 500 µL of S9-mix fraction is quickly added, before pouring the mixture onto the plates ; - or the pre-incubation assay where the solution of the test item solution with the test strain, and 500 µL of S9-mix fraction are preincubated with shaking for 30 min., at 37° C prior to mixing with the overlay agar and pouring onto the minimal agar plate.
1st assay:
- without metabolic activation: in agar (plate incorporation),
- with metabolic activation: in agar (plate incorporation)
2nd assay (this method used because the first assay was negative):
- without metbolic activation: in agar (plate incorporation),
- with metabolic activation: pre-incubation
DURATION
- Preincubation period: 30 min (at 37°C, with shaking)
- Exposure duration: 48-72 h
NUMBER OF REPLICATIONS: 3 plates per experimental point
DETERMINATION OF CYTOTOXICITY
- Method: Bacteriostatic activity was tested in all concentrations in strain TA 100 in a preliminary cytotoxicity experiment: percent of survival in the plates treated with test item concentrations compared to negative control colonies was measured. In a test tube, 0.1 mL of the bacterial suspension (1-9 x 10exp3 bacteria/mL) and 0.1 mL (in -aqueous or -oily vehicle / 50 µL (in non-aqueous or non-oily vehicle as ethanol ….) of the stock solution and dilutions, were successively added to 2 mL of top agar at 45°C, containing 10 % (v/v) of a solution of L-Histidine-D-Biotine (2.5 mM). After homogenization, the content of the tube was poured onto a Petri plate (90 mm in diameter) containing minimal agar (20 mL). 3 plates per concentration were incubated for 48-72 hours at 37°C, and the colonies counted. A negative control containing the blank alone was run in parallel.
In case bacteriostatic activity is detected, the highest concentration to be retained is that exhibiting a bacteriostatic activity of 75 % or less. The precipitate, if present, should not interfere with the scoring. The following four dilutions studied are distributed according to a semi-logarithmic progression. - Evaluation criteria:
- Study was judged to be valid if the following criteria were met:
- the bacteriostatic activity of the highest concentration tested is equal of less than 75%,
- the spontaneous reversion rate of the absolute negative control complies with the historical values of the laboratory,
- the spontaneous reversion rate of the solvent is not statistically different from absolute negative control,
- the mean number of revertant colonies obtained for each strain and the corresponding positive control, with and/or without metabolic activation complies with the historical values of the laboratory,
- negative and positive values don't show significant difference with the historical values of the laboratory (± 2 standard deviations).
Criteria for mutagenic activity in this assay:
The result of the test is considered as negative, if the revertant number is below three fold the number of spontaneous reversions, for TA 1535 and TA 1537 strains, and below two fold the number of spontaneous reversions for TA 98, TA 100 and Escherichia coli WP2 (uvrA-)(pKM101) strains without and with metabolic activation.
The result of the test is considered positive if a dependent relationship concentration is obtained in one, or several of the 5 strains, without and/or with metabolic activation, a mutagenic effect being taken into account for a given dilution of test item if the number of revertant colonies is at least two fold that of spontaneous revertant colonies for TA 98, TA 100 and Escherichia coli WP2 (uvrA-)(pKM101), and three fold for TA 1535 and TA 1537.
All results must be confirmed in an independent experiment. - Statistics:
- Mean values of replicates with standard deviations were calculated per plate.
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:
- valid
- 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:
- 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
- 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A pKM 101
- 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:
- RANGE-FINDING/SCREENING STUDIES:
Results of the bacteriostatic activity control testing show that neither original solution nor dilutions have bacteriostatic effect.
HISTORICAL CONTROL DATA (with number of experiments, ranges, means and standard deviation) (2009-2018)
POSITIVE HISTORICAL CONTROL DATA
TA 1535:
- without metabolic activation, plate incorporation, Sodium Azide: n=1017, range: 190 - 1487, mean: 757.7 ± 217.3
- with metabolic activation, plate incorporation, 2-Anthramine: n=540, range: 26 - 269, mean: 1112.9 ± 56.3
- with metabolic activation, pre-incubation, 2-Anthramine: n=534, range: 25 - 997, mean: 83.0 ± 77.7
TA 1537:
- without metabolic activation, plate incorporation, 9-Aminoacridine: n=1017, range: 224 - 1979, mean: 917.5 ± 465.2
- with metabolic activation, plate incorporation, 2-Anthramine: n=540, range: 24 - 170, mean: 55.4 ± 25.0
- with metabolic activation, pre-incubation, 2-Anthramine: n=534, range: 20 - 182, mean: 47.9 ± 25.3
TA 98:
- without metabolic activation, plate incorporation, 2-Nitrofluorene: n=1017, range: 187 - 1667, mean: 501.5 ± 219.9
- with metabolic activation, plate incorporation, 2-Anthramine: n=540, range: 220 - 1499, mean: 585.0 ± 225.6
- with metabolic activation, pre-incubation, 2-Anthramine: n=534, range: 174 - 1368, mean: 468.0 ± 207.4
TA 100:
- without metabolic activation, plate incorporation, Sodium Azide: n=1017, range: 381 - 1690, mean: 1038.8 ± 331.9
- with metabolic activation, plate incorporation, 2-Anthramine: n=537, range: 361 - 2163, mean: 850.7 ± 373.0
- with metabolic activation, pre-incubation, 2-Anthramine: n=537, range: 291 - 1720, mean: 640.5 ± 279.9
Escherichia coli WP2 (pKM101)(uvr A-)
- without metabolic activation, plate incorporation, cis-Platinium (II) Diamine Dichloride: n=819, range: 248 - 1089, mean: 485.4 ± 171.6
- with metabolic activation, plate incorporation, Dimethyl Benzanthracene: n=402, range: 365 - 1680, mean: 680.9 ± 246.8
- with metabolic activation, pre-incubation, Dimethyl Benzanthracene: n=420, range: 281 - 1680, mean: 668.0 ± 225.4
NEGATIVE (SOLVENT/VEHICLE) HISTORICAL CONTROL DATA
TA 1535:
- without metabolic activation, plate incorporation: n=1017, range: 4 - 23, mean: 11.0 ± 3.7
- with metabolic activation, plate incorporation: n=540, range: 3 - 23, mean: 12.3 ± 4.1
- with metabolic activation, pre-incubation: n=534, range: 5 - 25, mean: 12.9 ± 4.2
TA 1537:
- without metabolic activation, plate incorporation: n=1017, range: 1 - 20, mean: 6.1 ± 2.5
- with metabolic activation, plate incorporation: n=540, range: 1 - 24, mean: 8.0 ± 3.6
- with metabolic activation, pre-incubation: n=534, range: 1 - 21, mean: 8.2 ± 3.5
TA 98:
- without metabolic activation, plate incorporation: n=1017, range: 6 - 29, mean: 15.9 ± 3.9
- with metabolic activation, plate incorporation: n=540, range: 11 - 38, mean: 23.1 ± 5.2
- with metabolic activation, pre-incubation: n=534, range: 10 - 36, mean: 23.1 ± 5.4
TA 100:
- without metabolic activation, plate incorporation: n=1017, range: 40 - 121, mean: 60.1 ± 12.2
- with metabolic activation, plate incorporation: n=537, range: 55 - 152, mean: 90.8 ± 17.9
- with metabolic activation, pre-incubation: n=534, range: 51 - 156, mean: 90.5 ± 19.5
Escherichia coli WP2 (pKM101)(uvr A-)
- without metabolic activation, plate incorporation: n=819, range: 41 - 188, mean: 88.8 ± 36.3
- with metabolic activation, plate incorporation: n=420, range: 80 - 264.0, mean: 156.5 ± 34.0
- with metabolic activation, pre-incubation: n=420, range: 69 - 250, mean: 159.2 ± 36.1
Any other information on results incl. tables
Table #1: Assay n° 1, without metabolic activation, plate incorporation |
||||||||||
Concentration [µg/plate] | Revertant colonies / plate | |||||||||
TA 98 | TA 100 | TA 1535 | TA 1537 | E. coli WP2 uvrA | ||||||
mean±SD | R | mean±SD | R | mean±SD | R | mean±SD | R | mean±SD | R | |
Negative control | 16.00 ± 1.73 | - | 69.67 ± 4.51 | - | 9.33 ± 2.52 | - | 7.67 ± 2.31 | - | 159.00 ± 12.12 | - |
Vehicle (DMSO) | 17.33 ± 4.62 | - | 64.67 ± 5.51 | - | 13.00± 1.73 | - | 7.67 ± 3.51 | - | 169.00 ± 12.12 | - |
50 | 19.00 ± 0.00 | 1.10 | 59.33 ± 5.03 | 0.92 | 12.67 ± 2.52 | 0.97 | 7.00 ± 2.65 | 0.91 | 107.00 ± 8.72 | 0.70 |
150 | 15.33 ± 3.79 | 0.88 | 58.00 ± 2.00 | 0.90 | 11.67 ± 1.53 | 0.90 | 5.33 ± 2.52 | 0.70 | 125.00 ± 30.81 | 0.74 |
500 | 18.00 ± 2.00 | 1.04 | 54.67 ± 11.93 | 0.85 | 13.33 ± 2.08 |
1.03 |
4.43 ± 0.58 |
0.57 |
135.33 ± 12.50 |
0.80 |
1500 |
18.33 ± 4.16 |
1.06 |
58.00 ± 5.57 |
0.90 |
7.67 ± 2.89 |
0.59 |
6.00 ± 2.00 |
0.78 |
148.00 ± 24.58 |
0.88 |
5000 |
14.00 ± 3.61 |
0.81 |
57.00 ± 7.55 |
0.88 |
6.67 ± 2.08 |
0.51 |
5.33 ± 3.21 |
1.25 |
128.33 ± 20.03 |
0.76 |
Positive control solvent |
17.00 ± 5.20 |
- |
60.67 ± 2.08 |
- |
13.33 ± 2.08 |
- |
8.33 ± 0.58 |
- |
136.33 ± 5.51 |
- |
Positive control |
833.00 ± 38.00 |
49.00 |
1606.33 ± 47.44 |
26.48 |
950.67 ± 114.99 |
71.3 |
909.00 ± 94.17 |
109.08 |
303.33 ± 18.99 |
2.22 |
Table #2: Assay n° 1, with metabolic activation (10% S9 mix), plate incorporation |
||||||||||
Concentration [µg/plate] |
Revertant colonies / plate |
|||||||||
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
E. coli WP2 uvrA |
||||||
mean±SD |
R |
mean±SD |
R |
mean±SD |
R |
mean±SD |
R |
mean±SD |
R |
|
Negative control |
19.33 ± 4.51 |
- |
75.00 ± 8.72 |
- |
14.67 ± 1.51 |
- |
11.00 ± 3.61 |
- |
247.00 ± 9.00 |
- |
Vehicle (DMSO) |
19.67 ± 5.13 |
- |
81.67 ± 5.86 |
- |
15.67 ± 2.31 |
- | 10.00 ± 2.00 | - | 224.67 ± 6.11 | - |
50 | 17.33 ± 1.15 | 0.88 | 81.33 ± 2.08 | 1.00 | 13.33 ± 2.52 | 0.85 | 7.33 ± 3.79 | 0.73 | 237.00 ± 12.00 | 1.05 |
150 |
28.00 ± 2.65 |
1.42 |
79.33 ± 5.51 |
0.97 |
9.33 ± 1.53 |
0.60 |
9.33 ± 3.06 |
0.93 |
226.00 ± 24.58 |
1.01 |
500 |
27.00 ± 5.29 |
1.37 |
72.00 ± 5.57 |
0.88 |
11.00 ± 5.29 |
0.70 |
8.00 ± 2.65 |
0.80 |
220.00 ± 16.09 |
0.98 |
1500 |
27.00 ± 5.29 |
1.37 |
66.67 ± 13.65 |
0.82 |
9.67 ± 3.06 |
0.62 |
8.67 ± 4.51 |
0.87 |
232.00 ± 27.62 |
1.03 |
5000 |
24.67 ± 4.62 |
1.25 |
71.00 ± 6.56 |
0.87 |
9.33 ± 6.81 |
0.60 |
9.67 ± 3.51 |
0.97 |
268.33 ± 17.56 |
1.19 |
Positive control solvent |
21.00 ± 5.29 |
- |
76.67 ± 11.59 |
- |
17.00 ± 2.00 |
- |
9.00 ± 2.65 |
- |
214.00 ± 1.73 |
- |
Positive control |
430.33 ± 90.14 |
23.45 |
625.00 ± 118.65 |
8.15 |
106.33 ± 27.54 |
6.25 |
47.00 ± 12.53 |
5.22 |
477.33 ± 21.83 |
2.23 |
Table #3: Assay n° 2, without metabolic activation, plate incorporation |
||||||||||
Concentration [µg/plate] |
Revertant colonies / plate |
|||||||||
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
E. coli WP2 uvrA |
||||||
mean±SD |
R |
mean±SD |
R |
mean±SD |
R |
mean±SD |
R |
mean±SD |
R |
|
Negative control |
12.67 ± 3.79 |
- |
56.67 ± 7.64 |
- |
8.67 ± 4.73 |
- |
4.33 ± 0.58 |
- |
95.00 ± 14.42 |
- |
Vehicle (DMSO) |
14.67 ± 5.77 |
- |
67.67 ± 1.53 |
- |
15.00 ± 5.20 |
- |
3.00 ± 2.00 |
- |
93.33 ± 11.93 |
- |
50 |
16.67 ± 0.58 |
1.14 |
49.00 ± 2.65 |
0.72 |
11.67 ± 4.04 |
0.78 |
3.67 ± 2.31 |
1.22 |
78.67 ± 3.21 |
0.84 |
150 |
17.00 ± 1.73 |
1.73 |
53.00 ± 7.81 |
0.78 |
10.00 ± 1.00 |
0.67 |
5.00 ± 4.36 |
1.67 |
90.33 ± 5.69 |
0.97 |
500 |
12.33 ± 4.93 |
0.84 |
48.33 ± 2.31 |
0.71 |
8.33 ± 1.53 |
0.56 |
4.33 ± 1.15 |
1.44 |
80.00 ± 2.65 |
0.86 |
1500 |
12.00 ± 3.46 |
0.82 |
54.67 ± 4.73 |
0.81 |
6.67 ± 1.15 |
0.44 |
4.67 ± 2.08 |
1.56 |
74.00 ± 9.85 |
0.79 |
5000 |
13.00 ± 5.20 |
0.89 |
47.00 ± 4.58 |
0.69 |
7.67 ± 2.08 |
0.51 |
3.67 ± 2.89 |
1.22 |
73.00 ± 5.29 |
0.78 |
Positive control solvent |
10.00 ± 6.08 |
- |
61.00 ± 3.00 |
- |
12.33 ± 4.04 |
- |
2.00 ± 1.73 |
- |
72.33 ± 10.07 |
- |
Positive control |
363.67 ± 37.17 |
36.17 |
1363.00 ± 145.32 |
22.34 |
1265.00 ± 63.93 |
102.57 |
631.33 ± 99.73 |
118.22 |
302.33 ± 54.45 |
4.18 |
Table #4: Assay n° 2, with metabolic activation, pre-incubation |
||||||||||
Concentration [µg/plate] |
Revertant colonies / plate |
|||||||||
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
E. coli WP2 uvrA |
||||||
mean±SD |
R |
mean±SD |
R |
mean±SD |
R |
mean±SD |
R |
mean±SD |
R |
|
Negative control |
16.67 ± 1.15 |
- |
79.67 ± 6.43 |
- |
17 -33 ± 1.53 |
- |
5.33 ± 3.51 |
- |
134.67 ± 8.33 |
- |
Vehicle (DMSO) |
22.67 ± 7.51 |
- |
100.67 ± 10.02 |
- |
11.67 ± 4.16 |
- |
5.33 ± 4.16 |
- |
113.67 ± 12.50 |
- |
50 |
22.33 ± 9.81 |
0.99 |
65.33 ± 4.93 |
0.65 |
11.00 ± 2.00 |
0.94 |
7.00 ± 1.00 |
1.31 |
121.33 ± 6.66 |
1.07 |
150 |
14.00 ± 1.73 |
0.62 |
69.67 ± 13.58 |
0.69 |
9.00 ± 7.00 |
0.77 |
5.00 ± 1.73 |
0.94 |
141.33 ± 3.21 |
1.24 |
500 |
23.00 ± 10.39 |
1.01 |
78.00 ± 10.82 |
0.77 |
7.00 ± 3.00 |
0.60 |
7.67 ± 2.08 |
1.44 |
137.00 ± 8.72 |
1.21 |
1500 |
23.00 ± 8.66 |
1.01 |
79.33 ± 4.93 |
0.79 |
10.00 ± 3.61 |
0.86 |
4.33 ± 0.58 |
0.81 |
135.33 ± 3.06 |
1.19 |
5000 |
12.67 ± 2.89 |
0.56 |
57.33 ± 3.79 |
0.57 |
5.67 ± 1.53 |
0.49 |
4.00 ± 1.00 |
0.75 |
142.67 ± 10.41 |
1.26 |
Positive control solvent |
17.67 ± 8.33 |
- |
73.00 ± 7.81 |
- |
14.33 ± 5.51 |
- |
5.67 ± 2.08 |
- |
142.67 ± 3.06 |
- |
Positive control |
247.67 ± 17.90 |
14.02 |
329.33 ± 37.81 |
4.51 |
41.67 ± 11.59 |
2.91 |
28.33 ± 3.51 |
5.00 |
340.00 ± 70.00 |
2.38 |
SD = Standard deviation; R = Number of revertant colonies in the presence of the test item/ Number of revertant colonies in the absence of the test item
Applicant's summary and conclusion
- Conclusions:
- Doses (5 000, 1 500, 500, 150 and 50 µg/plate) prepared from solutions of the test item 2-Hexyldecanoic acid do not induce any mutagenic change in Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100 and in Escherichia coli WP2(uvrA¯) (pKM 101) without, or with metabolic activation, according to the OECD Guideline n° 471.
- Executive summary:
A bacterial reverse mutation test using Salmonella typhimurium his- and Escherichia coli WP2 (uvrA-)(pKM101) was performed according to OECD Guideline n°471 in compliance with Good Laboratory Practices (GLP).
Solutions obtained from the test item have been tested for their capacity to induce reverse mutation in four Salmonella typhimurium strains and one Escherichia coli WP2 (uvrA-)(pKM101) strain. This study was performed in the absence and presence of metabolic activation. Two independent assays were carried out. For assay n°1, various concentrations were put in contact with the strains in the absence and presence of a metabolic activation system (S9 -mix 10% (v/v)). For assay n°2, various concentrations were put in contact with test strains in absence and presence of a metabolic activation system (S9 -mix 10%(v/v)). For the two assays, negative and postive controls were carried out in parallel. Positive controls induced a significant increase in the number of revertant colonies compared to negative controls. There was no siginificant difference between the number of spontaneous reversions, the number of reversions obtained in the prositive controls (without and with metabolic activation), and the mean of corresponding experimental "historical" values obtained in the laboratory. These results validated the two tests. There was no evidence of any increase in the number of revertant colonies in the presence of the various concentrations of the test item (50, 150, 500, 1500, and 5000 µg/plate), without and with metabolic activation in Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100, and in Escherichia coli WP2 (uvrA-)(pKM101). The test item was judged to be non-mutagenic in this test system under the described conditions.
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