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EC number: 269-124-2 | CAS number: 68187-77-9
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Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- other: read across from analogue substance
- Adequacy of study:
- key study
- Study period:
- From 10 August to 04 October 2010
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- Oils, fish, oxidized, bisulfited, sodium salts
- EC Number:
- 307-037-4
- EC Name:
- Oils, fish, oxidized, bisulfited, sodium salts
- Cas Number:
- 97488-98-7
- IUPAC Name:
- Oils, fish, oxidized, bisulfited, sodium salts
- Details on test material:
- Name of test material (as cited in study report): FLL sample 3
- Physical state: viscous liquid
- Lot/batch No.: LS06921
- Expiration date of the lot/batch: 13 October 2010
- Storage condition of test material: room temperature in the dark
- Other: amber color
- All other template details: Not reported
Constituent 1
Method
- Target gene:
- thymidine kinase, TK +/-, locus
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- Type and identity of media: RPMI 1640 culture medium with Glutamax-1 and HEPES buffer (20 mM) supplemented with Penicillin (100 units/ml), Streptomycin (100 µg/ml), Sodium pyruvate (1 mM), Amphotericin B (2.5 µg/ml) and 10% donor horse serum (giving R10 media) at 37 degrees C with 5% CO2 in air
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: no
- Periodically checked for karyotype stability: yes
- Periodically "cleansed" against high spontaneous background: yes - Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- PB/BNF S9 prepared from livers of male Sprague-Dawley rats weighing approximately 250g
- Test concentrations with justification for top dose:
- preliminary test (µg/ml): 0, 19.53, 39.06, 78.13, 156.25, 312.5, 625, 1250, 2500, 3750
main test (µg/ml): 0, 75, 150, 300, 600, 700, 800, 900, 1000, 1100, 1200 - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: not reported
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- ethylmethanesulphonate : Sigma batch 0001423147 for positive control in absence of metabolic activation
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- Cyclophosphamide (CP) Acros batch A0277203 was used as the positive control in the presence of metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 4 hours with metabolic activation, 4 and 24 hours without metabolic activation
- Expression time (cells in growth medium): two days
- Fixation time (start of exposure up to fixation or harvest of cells): 52-72 hours
SELECTION AGENT (mutation assays): 4 µg/ml 5-trifluorothymidine (TFT)
NUMBER OF REPLICATIONS: 2
NUMBER OF CELLS EVALUATED: 1 x 10^6 cells/ml
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth, viability
OTHER EXAMINATIONS:
- Other: determination of mutation frequency
OTHER: not applicable - Evaluation criteria:
- Any test material dose level that has a mutation frequency value that is greater than the corresponding vehicle control by the GEF of 126 x 10-6 will be considered positive.
- Statistics:
- The UKEMS statistical package was used to determine significant increases in mutant colonies.
Results and discussion
Test results
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- cytotoxicity observed at highest tested concentration
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: in the first study, a precipitate of test material was observed at and above 150 μg/ml in the absence of metabolic activation, and at and above 300 μg/ml in the presence of metabolic activation. In the second study, a precipitate of test material was observed at and above 150 µg/ml in both exposure groups.
- Other confounding effects: not reported
RANGE-FINDING/SCREENING STUDIES: the preliminary study showed a marked reduction in relative suspension growth % between 625 and 1250 µg/ml. In the subsequent mutagenicity test, the maximum dose level was limited by test material-induced toxicity. A precipitate was observed at and above 156.25 µg/ml in the 4-hour exposure groups, and at and above 78.13 µg/ml in the 24-hour exposure group.
COMPARISON WITH HISTORICAL CONTROL DATA: the positive and vehicle control responses were within historical data
ADDITIONAL INFORMATION ON CYTOTOXICITY: Summary of results are shown in Tables 1 and 2. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1. Summary of Results: Experiment 1
Treatment (µg/ml) |
4-Hours without S-9 |
Treatment (µg/ml) |
4-Hours with S-9 |
||||
|
% RSG |
RTG |
MF |
|
% RSG |
RTG |
MF |
0 |
100 |
1.00 |
86.67 |
0 |
100 |
1.00 |
109.06 |
75 |
114 |
|
|
75 |
97 |
|
|
150 |
111 |
|
|
150 |
105 |
|
|
300 |
113 |
|
|
300 |
102 |
|
|
600 |
99 |
1.00 |
132.66 |
600 |
94 |
0.94 |
140.40 |
700 |
95 |
1.11 |
84.16 |
700 |
74 |
0.79 |
133.39 |
800 |
91 |
1.03 |
103.56 |
800 |
78 |
0.87 |
117.68 |
900 |
89 |
0.87 |
109.87 |
900 |
74 |
0.87 |
95.67 |
1000 |
69 |
0.69 |
119.94 |
1000 |
46 |
0.41 |
113.54 |
1100 |
9 |
0.13 |
108.70 |
1100 |
4 |
0.04 |
179.53 |
1200 |
1 |
|
|
1200 |
2 |
|
|
Linear Trend = Not Significant |
Linear Trend = Not Significant |
||||||
EMS |
|
|
|
CP |
|
|
|
400 |
76 |
0.4 |
859.95 |
2 |
63 |
0.37 |
1185.45 |
Table 2. Summary of Results: Experiment 2
Treatment (µg/ml) |
4-Hours without S-9 |
Treatment (µg/ml) |
4-Hours with S-9 |
||||
|
% RSG |
RTG |
MF |
|
% RSG |
RTG |
MF |
0 |
100 |
1.00 |
114.51 |
0 |
100 |
1.00 |
161.92 |
75 |
95 |
|
|
75 |
112 |
|
|
150 |
89 |
|
|
150 |
112 |
|
|
300 |
87 |
0.96 |
100.01 |
300 |
108 |
1.14 |
117.09 |
600 |
56 |
0.59 |
131.16 |
600 |
96 |
1.10 |
101.92 |
700 |
40 |
0.49 |
147.69 |
700 |
92 |
1.16 |
87.96 |
800 |
36 |
0.40 |
160.16 |
800 |
78 |
0.86 |
107.66 |
900 |
28 |
0.30 |
177.82 |
900 |
52 |
0.57 |
105.15 |
1000 |
18 |
0.18 |
175.16 |
1000 |
10 |
0.08 |
116.36 |
1100 |
14 |
0.12 |
140.86 |
1100 |
0 |
|
|
1200 |
7 |
|
|
1200 |
0 |
|
|
Linear Trend = Not Significant |
Linear Trend = Not Significant |
||||||
EMS |
|
|
|
CP |
|
|
|
150 |
55 |
0.47 |
1668.52 |
2 |
94 |
0.74 |
669.89 |
** RSG = Relative Suspension Growth Rate
** RTG = Relative Total Growth
** MF = Mutation Frequency
Applicant's summary and conclusion
- Conclusions:
- The substance was tested for OECD 476. Under the experimental conditions the test item was considered to be non-mutagenic to L5178Y cells.
- Executive summary:
Introduction. The study was conducted according to a method that was designed to assess the potential mutagenicity of the test material on the thymidine kinase, TK +/-, locus of the L5178Y mouse lymphoma cell line. The method used meets the requirements of the OECD (476) and Method B17 of Commission Regulation (EC) No. 440/2008 of 30 May 2008.
Methods. Two independent experiments were performed. In Experiment 1, L5178Y TK +/- 3.7.2c mouse lymphoma cells (heterozygous at the thymidine kinase locus) were treated with the test material at ten dose levels, in duplicate, together with vehicle (solvent) and positive controls using 4-hour exposure groups both in the absence and presence of metabolic activation (2% S9). In Experiment 2, the cells were treated with the test material at ten dose levels using a 4-hour exposure group in the presence of metabolic activation (1% S9) and a 24-hour exposure group in the absence of metabolic activation.
The dose range of test material was selected following the results of a preliminary toxicity test and was 75 to 1200 μg/ml, in both the absence and presence of metabolic activation, for both the first and second experiments.
Results. The maximum dose level used in the mutagenicity test was limited by test material-induced toxicity. A precipitate of test material was observed at and above 150 μg/ml in the absence of metabolic activation, and at and above 300 μg/ml in the presence of metabolic activation in the first experiment. A precipitate of test material was observed at and above 150 μg/ml in both the absence and presence of metabolic activation in the second experiment. The vehicle (solvent) controls had acceptable mutant frequency values that were within the normal range for the L5178Y cell line at the TK +/- locus. The positive control materials induced marked increases in the mutant frequency indicating the satisfactory performance of the test and of the activity of the metabolising system.
The test material did not induce any toxicologically significant dose-related increases in the mutant frequency at any dose level, either with or without metabolic activation, in either the first or the second experiment.
Conclusion. The test material was considered to be non-mutagenic to L5178Y cells under the conditions of the test.
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