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EC number: 701-234-2 | CAS number: 18402-84-1
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- Short-term toxicity to fish
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Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2009-04-16 to 2009-09-01
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Version / remarks:
- adopted 21th July 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.17 (Mutagenicity - In Vitro Mammalian Cell Gene Mutation Test)
- Version / remarks:
- dated 30th May 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian cell gene mutation tests using the thymidine kinase gene
Test material
- Reference substance name:
- (3E)-dec-3-en-2-one
- Cas Number:
- 18402-84-1
- Molecular formula:
- C10H18O
- IUPAC Name:
- (3E)-dec-3-en-2-one
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- - Name: AMW-1018
- Purity: 98% w/w
- Batch No: 3D2-2009/01
- Physical state: liquid
- Colour: pale yellow
- Storage conditions: refrigerator 5 +/-3 °C; protected from light keep under nitrogen
- Expiry date: December 2010
Method
- Target gene:
- Thymidine kinase (TK)
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- CELLS USED
- Type of cells: Mouse Lymphoma L5178Y cells which are heterozygous at the Thymidine Kinase (TK) locus
- Source: BSL stock cultures
MEDIA USED
- RPMI 1640 supplemented with: 9.0 µg/mL hypoxanthine, 15.0 µg/mL thymidine, 22.5 µg/mL glycine and 0.1 µg/mL methotrexate.
The cells are resuspended in medium without methotrexate but thymidine, hypoxanthine and glycine for 1-3 days.
- Complete Culture Medium:
RPMI 1640 medium supplemented with 15% horse serum, 100U/100 µg/mL penicillin/streptomycin, 1mM sodium pyruvate, 2mM L-glutamine, 25 mM HEPES, 250 µg/mL amphotericin B
- Treatment Medium:
RPMI 1640 medium supplemented with 3% horse serum (short-term exposure), 7.5% horse serum (long-term exposure), 100U/100 µg/mL penicillin/streptomycin, 1mM sodium pyruvate, 2 mM L-glutamine, 25 mM HEPES and 250 µg/mL amphotericin B
- Selective Medium: RPMI 1640 complete culture medium supplemented with TFT (5 µg/mL)
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- Pre-test for toxicity:
Short term:
with S9 mix
0, 0.005, 0.01, 0.05, 0.10, 0.20, 0.40 mM
without S9 mix
0, 0.005, 0.01, 0.05, 0.10, 0.20 mM
Long-term (24 hours):
without S9 mix: 0.001, 0.005, 0.01, 0.05, 0.1 and 0.2 mM
Main test:
Experiment I:
with S9 mix
0.05, 0.15, 0.22, 0.25, 0.28, 0.31, 0.34, 0.37 mM
without S9 mix
0.005, 0.01, 0.02, 0.05, 0.10, 0.12, 0.14, 0.16 mM
Experiment II:
with S9 mix
0.10, 0.15, 0.19, 0.23, 0.27, 0.31, 0.35, 0.38 mM
without S9 mix
0.0001, 0.0007, 0.004, 0.007, 0.014, 0.028, 0.034, 0.04 mM - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Dimethylsulfoxide (DMSO)
- Justification for choice of solvent/vehicle: The solvent was compatible with the survival of the cells and the S9 activity
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- Treatment medium
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- without metabolic activation, final concentration 200 µg/mL and 500 µg/mL
- Untreated negative controls:
- yes
- Remarks:
- Treatment medium
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- without metabolic activation, final concentration 10 µg/mL
- Untreated negative controls:
- yes
- Remarks:
- Treatment medium plus S9
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- with metabolic activation, final concentrations 2.5 - 3.5 µg/mL
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
- Cell density at seeding (if applicable): 1x10^7 cells suspended in 11 mL RPMI medium with 3% horse serum
DURATION
- Preincubation period: none
- Exposure duration: 4 hours (Experiment I, Experiment II with S9); 24 hours (Experiment II, without S9)
- Expression time (cells in growth medium): 3 days
- Selection time (if incubation with a selection agent): 11-14 days
DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency and relative total growth
SELECTION AGENT (mutation assays): Trifluorothymidine (TFT)
METHODS FOR MEASUREMENTS OF GENOTOXICIY
The mutation frequencies were calculated from the data obtained from cultures used for the coloning efficiency and those used for selection in the following number:
- Mutation frequency= ((-ln [NC/TC (selective medium)])/ (-ln [NC/TC (non selective medium)]) x 800 - Rationale for test conditions:
- n.a.
- Evaluation criteria:
- There are several criteria for determining a positive result:
- clear and dose-related increase in the mutant frequency
- biological relevant response (at least 2-fold increase of mutant frequencies related to the respective negative control values and higher than the historical range of negative controls) for at least one of the dose groups
- combined with a positive effect in the mutant frequency, an increased occurence of small colonies (slow growth colonies) indicated by a low large/small colonies ratio (1.5 times the ratio of clatogenic controls MMS and/or B[a]P is an indication for potential clastogenic effects and/or chromosomal aberrations.
According to the OECD guidelines, the biological relevance is the criterion for the interpretation of results. A statistical evaluation of the results is not regarded as necessary. A test item is considered to be negative if there is no biologically relevant increase in the induction of mutant cells above concurrent control levels, at any dose level. - Statistics:
- Not required
Results and discussion
Test resultsopen allclose all
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- Experiment I
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- In experiment I, the relative total growth (RTG) was 12.22% and 13.71% for the highest concentrations (0.37 and 0.16 mM) evaluated with and without metabolic activation respectively.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with
- Genotoxicity:
- ambiguous
- Remarks:
- Experiment II
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- In experiment II, the relative total growth (RTG) was 9.20% and 13.16% for the highest concentrations (0.38 and 0.04 mM) evaluated with and without metabolic activation respectively.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Remarks:
- Experiment II
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- In experiment II, the relative total growth (RTG) was 9.20% and 13.16% for the highest concentrations (0.38 and 0.04 mM) evaluated with and without metabolic activation respectively.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- Toxicity: In experiment I, the relative total growth (RTG) was 12.22% and 13.71% for the highest concentrations (0.37 and 0.16 mM) evaluated with and without metabolic activation respectively. In experiment II, the relative total growth (RTG) was 9.20% and 13.16% for the highest concentrations (0.38 and 0.04 mM) evaluated with and without metabolic activation respectively.
Mutagenicity: In experiment I with metabolic activation, all mutant values found were within the historical control data of the test facility BSL BIOSERVICE, no dose-relationship was observed and the mutation frequencies found in the treated groups did not show a biologically relevant increase compared to solvent controls. Without metabolic activation, all mutant values found were within or slightly above the historical control data of the test facility. Even though a slight dose-response relationship was observed, the higher mutant value at 0.16 mM was considered as biologically not relevant due to the lack of mutagenicity. However, this should be verified in an independent repetition experiment.
In experiment II with metabolic activation, some of the mutant values found were within the historical control data of the test facility. Some of the mutant values (at doses of 0.27, 0.31 and 0.38 mM) clearly exceeded the range of historical control data. Two dose groups (0.31 and 0.38 mM) the threshold value of 2 for the mutation factor was slightly exceeded and a slight dose response relationship could be observed. However, since in experiment I no mutagenicity was evaluated up to an RTG of 12.22% these results are considered to be equivocal. In experiment II without metabolic activation all mutant values found up to the dose of 0.0014 mM were within the historical control data of the test facility. At doses from 0.028 mM the data exceeded the historical control range. In addition, in these dose groups the threshold value of 2 for the mutation factor was exceeded and a dose-response relationship could be observed
Relationship of large to small colonies: Colony sizing was performed for the highest concentrations of the test item and for the controls. A mutation frequency above 2 in combination with an increased occurrence of small colonies is an indication for potential clastogenic effects and/or chromosomal aberrations.
In experiment I with metabolic activation in the highest dose groups tested and increased number of small colonies was noted. However, no clear corresponding mutagenicity was found in these dose groups so no clear conclusion could be drawn. To clarify the findings an independent repetition was performed. In experiment I without metabolic activation, all dose groups were considered to be not clastogenic.
In experiment II with metabolic activation, the increases in the number of small colonies noted at doses of 0.31 mM and 0.38 mM showed clastogenicity since in this experiment for these dose groups the threshold value for mutagenicity was exceeded. Without metabolic activation, an increase in small colonies noted at a dose of 0.034 mM suggests clastogenicity since corresponding mutagenicity was found in this dose group.
Ethyl methane sulfonate (EMS), methyl methane sulfonate (MMS) and benzo-a-pyrene (BaP) were used as positive controls and showed distinct and biologically relevant effects in mutation frequency. Additionally, MMS and BaP significantly increased the number of small colonies, thus validating the test system.
Any other information on results incl. tables
Table 1: Results experiment I with metabolic activation
Dose (mM) |
RSG (%) |
RCE (%) |
RTG (%) |
Mutants/10^6 cells |
MF |
No. Large Colonies |
No. Small Colonies |
|
NC1 |
94.32 |
103.5 |
97.19 |
121.78 |
- |
84 |
22 |
|
NC2 |
91.36 |
106.10 |
96.93 |
147.76 |
- |
111 |
25 |
|
S1 |
100.00 |
100.00 |
100.00 |
162.23 |
- |
98 |
90 |
|
S2 |
100.00 |
100.00 |
100.00 |
168.06 |
- |
93 |
31 |
|
0.05 |
97.41 |
103.05 |
10.38 |
142.69 |
0.86 |
- |
- |
|
0.15 |
90.97 |
98.17 |
89.31 |
191.81 |
1.16 |
|||
0.22 |
78.42 |
107.93 |
84.64 |
146.18 |
0.89 |
|||
0.25 |
70.58 |
106.71 |
75.32 |
163.45 |
0.99 |
|||
0.28 |
51.20 |
103.66 |
53.07 |
192.50 |
1.17 |
|||
0.31 |
36.61 |
101.83 |
37.28 |
225.79 |
1.37 |
95 |
73 |
|
0.34 |
21.19 |
100.61 |
21.32 |
244.20 |
1.48 |
100 |
73 |
|
0.37 |
13.09 |
93.29 |
12.22 |
315.01 |
1.91 |
101 |
78 |
|
BaP 3.5 µg/mL |
42.03 |
103.66 |
43.57 |
432.60 |
2.62 |
133 |
132 |
|
Table 2: Results experiment I without metabolic activation
Dose (mM) |
RSG (%) |
RCE (%) |
RTG (%) |
Mutants/10^6 cells |
MF |
No. Large Colonies |
No. Small Colonies |
NC1 |
115.95 |
105.04 |
121.79 |
96.88 |
- |
74 |
28 |
NC2 |
115.95 |
105.04 |
118.26 |
88.96 |
- |
78 |
19 |
S1 |
100 |
100 |
100 |
127.92 |
- |
108 |
13 |
S2 |
100 |
100 |
100 |
158.58 |
- |
105 |
15 |
0.005 |
93.55 |
90.80 |
84.94 |
178.64 |
1.25 |
- |
- |
0.01 |
95.89 |
99.70 |
95.60 |
124.27 |
0.87 |
||
0.02 |
88.87 |
104.45 |
92.83 |
97.12 |
0.68 |
||
0.05 |
71.75 |
93.77 |
67.28 |
141.04 |
0.98 |
||
0.10 |
38.14 |
96.14 |
36.67 |
200.76 |
1.40 |
||
0.12 |
27.05 |
97.92 |
26.49 |
193.38 |
1.35 |
91 |
54 |
0.14 |
18.60 |
93.18 |
17.33 |
234.81 |
1.64 |
100 |
51 |
0.16 |
13.96 |
94.36 |
13.17 |
265.61 |
1.85 |
90 |
80 |
EMS 500 µg/mL |
77.55 |
100.89 |
78.24 |
738.31 |
5.15 |
dng |
dng |
MMS 10 µg/mL |
86.60 |
100.30 |
86.86 |
388.56 |
2.71 |
103 |
144 |
Table 3: Results experiment II with metabolic activation
Dose (mM) |
RSG (%) |
RCE (%) |
RTG (%) |
Mutants/10^6 cells |
MF |
No. Large Colonies |
No. Small Colonies |
NC1 |
11.68 |
95.91 |
107.11 |
168.48 |
- |
107 |
21 |
NC2 |
103.73 |
100.58 |
104.33 |
151.80 |
- |
115 |
19 |
S1 |
100 |
100 |
100 |
138.41 |
- |
111 |
32 |
S2 |
100 |
100 |
100 |
190.20 |
- |
116 |
23 |
0.1 |
97.06 |
100 |
97.06 |
188.45 |
1.15 |
- |
- |
0.15 |
98.39 |
94.74 |
93.22 |
222.77 |
1.36 |
||
0.19 |
85.13 |
95.32 |
81.15 |
181.65 |
1.11 |
||
0.23 |
74.59 |
99.42 |
74.15 |
219.37 |
1.34 |
||
0.27 |
53.95 |
95.91 |
51.74 |
307.97 |
1.87 |
||
0.31 |
42.47 |
85.96 |
36.51 |
365.24 |
2.22 |
125 |
61 |
0.35 |
21.44 |
97.66 |
20.93 |
246.30 |
1.50 |
110 |
69 |
0.38 |
10.42 |
88.30 |
9.20 |
353.79 |
2.15 |
135 |
55 |
BaP 3.5 µg/mL |
42.03 |
93.74 |
33.30 |
1322.40 |
8.05 |
183 |
105 |
Table 4: Results experiment II without metabolic activation
Dose (mM) |
RSG (%) |
RCE (%) |
RTG (%) |
Mutants/10^6 cells |
MF |
No. Large Colonies |
No. Small Colonies |
NC1 |
141.19 |
95.43 |
134.73 |
179.57 |
- |
119 |
22 |
NC2 |
120.38 |
92.57 |
111.44 |
176.43 |
- |
115 |
14 |
S1 |
100 |
100 |
100 |
122.40 |
- |
96 |
23 |
S2 |
100 |
100 |
100 |
117.46 |
- |
92 |
23 |
0.0001 |
100.59 |
98.86 |
99.44 |
162.56 |
1.36 |
- |
- |
0.0007 |
97.97 |
99.43 |
97.41 |
115.30 |
0.96 |
||
0.004 |
98.53 |
95.43 |
94.03 |
163.74 |
1.37 |
||
0.007 |
80.10 |
95.43 |
76.44 |
153.03 |
1.28 |
||
0.014 |
61.51 |
95.43 |
58.70 |
177.95 |
1.48 |
||
0.028 |
33.36 |
89.71 |
29.93 |
340.70 |
2.84 |
141 |
57 |
0.034 |
20.43 |
85.71 |
17.51 |
435.14 |
3.63 |
104 |
112 |
0.04 |
15.05 |
87.43 |
13.16 |
495.78 |
4.13 |
132 |
109 |
EMS 200 µg/mL |
82.51 |
80.57 |
66.48 |
1172.73 |
9.78 |
- |
- |
MMS 10 µg/mL |
54.50 |
52.57 |
28.65 |
1986.63 |
16.57 |
123 |
185 |
NC Negative Control; S Solvent control; RSG Relative Suspension Growth; RCE Relative Cloning Efficiency; RTG Relative Total Growth; MF (mutation frequency); dng data not given; BaP Benz(a)pyrene; EMS = ethyl methane sulfonate; MMS = methyl methane sulfonate
Applicant's summary and conclusion
- Conclusions:
- In conclusion, in the described mutagenicity test under the experimental conditions reported, the test item 3-decen-2-one is considered to be mutagenic in the mouse lymphoma thymidine kinase locus assay using the cell line L5178Y in the absence of metabolic activation.
- Executive summary:
In a mammalian cell gene mutation assay using the Thymidine Kinase Gene conducted according to OECD Guideline 476, mouse lymphoma L5178Y cells cultured in vitro were exposed to (3E)-dec-3-en-2-one (98% purity) for 4 hours at concentrations of 0.05, 0.15, 0.22, 0.25, 0.27, 0.31, 0.34, 0,37 mM with S9 metabolic activation and at concentrations 0.005, 0.01, 0.02, 0.05,0.10,0.12, 0.14 and 0.16 mM without S9 metabolic activation in experiment I. In experiment II (4-hour exposure, with S9) the following concentrations were tested: 0.10, 0.15, 0.19, 0.23, 0.27, 0.31, 0.35 and 0,38 mM. Experiment II without S9 metabolic activation was performed as a 24-hour long-term exposure assay with the following concentrations tested: 0.0001, 0.0007, 0.004, 0.007, 0.014, 0.028, 0.034 and 0.4 mM. The selection of the concentrations used in the main experiment was based on data from the pre-experiment.
No precipitation of the test item was noted in the experiments. Growth inhibition was observed in experiments I and II with and without metabolic activation. In experiment I, the relative total growth (RTG) was 12.22% and 13.71% for the highest concentrations (0.37 and 0.16 mM) evaluated with and without metabolic activation respectively. In experiment II, the relative total growth (RTG) was 9.20% and 13.16% for the highest concentrations (0.38 and 0.04 mM) evaluated with and without metabolic activation respectively.
In experiment I (both with and without metabolic activation) no biologically relevant increase in mutants was found after treatment with the test item. A second experiment was performed to confirm these results. In experiment II with metabolic activation, the effect of the test item on mutation frequency was considered equivocal. In experiment II without metabolic activation, a biologically relevant increase in mutants was found after treatment with the test item. Additionally, a dose-response relationship was observed, and colony sizing showed clastogenic effects induced by the test item under the experimental conditions (without metabolic activation). The positive controls showed distinct and biologically relevant effects in mutation frequency, thus validating the test system.
In conclusion, in the described test under the experimental conditions reported 3-decen-2-one is considered to be mutagenic in the mouse lymphoma thymidine kinase locus using the cell line L5178Y without metabolic activation.
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