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EC number: 203-537-0 | CAS number: 107-96-0
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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:
- key study
- Study period:
- 03 March 2008 to 28 April 2008.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- minor deviations; absence of clastogenic control (-S9) is not essential for the interpretation of the study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- yes
- Remarks:
- a clastogenic positive control was not used -S9; not essential for the interpretation of the study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.17 (Mutagenicity - In Vitro Mammalian Cell Gene Mutation Test)
- Version / remarks:
- adopted 2000
- Deviations:
- yes
- Remarks:
- a clastogenic positive control was not used -S9; not essential for the interpretation of the study
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- 3-mercaptopropionic acid
- EC Number:
- 203-537-0
- EC Name:
- 3-mercaptopropionic acid
- Cas Number:
- 107-96-0
- Molecular formula:
- C3H6O2S
- IUPAC Name:
- 3-sulfanylpropanoic acid
- Details on test material:
- - Name of test material (as cited in study report): 3-Mercaptopropionic acid
- Physical state: Clear colourless liquid
- Analytical purity: 99.8% (GC)
- Purity test date: 2008-02-21
- Lot/batch No.: 22333
- Expiration date of the lot/batch: 2009-02-19
- Stability under test conditions: no data
- Storage condition of test material: room temperature in the dark
Constituent 1
Method
- Target gene:
- thymidine kinase
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- - Type and identity of media: RPMI 1640 medium
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: no data
- Periodically checked for karyotype stability: no data
- Periodically "cleansed" against high spontaneous background: yes - Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 was prepared from the livers of male Sprague-Dawley rats weighing ~250 g. These had each orally received three consecutive daily doses of phenobarbitone/ß-naphthoflavone (80/100 mg per kg per day) prior to S9 preparation on Day 4.
- Test concentrations with justification for top dose:
- Exp. 1 : +/- S9: 66.31, 132.63, 265.25, 530.5, 705.75, and 1061 µg/ml;
Exp 2:
4 hr w/ S9: 66.31, 132.63, 265.25, 530.5, 705.75, and 1061 µg/ml;
24 hr w/o S9: 16.5, 33, 66, 99, 132, and 198 µg/ml - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: serum-free culture medium
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- without S9
Migrated to IUCLID6: 400 / 150 µg/mL (4 / 24 h exposure)
- Positive control substance:
- cyclophosphamide
- Remarks:
- with S9
Migrated to IUCLID6: 2 µg/mL
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 4, 24 h
- Expression time (cells in growth medium): 2 days
- Selection time (if incubation with a selection agent): 10-14 days
SELECTION AGENT (mutation assays): 4 µg/mL 5-trifluorothymidine
NUMBER OF REPLICATIONS: 2
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth
- Evaluation criteria:
- For a test material to demonstrate a mutagenic response it must produce a statistically significant increase in the induced mutant frequency (IMF) over the concurrent vehicle mutant frequency value.The IMF must exceed some value based on the global background MF for each method (agar or microwell). This Global Evaluation Factor (GEF) value was set at 126E-06 for the microwell method. Therefore any test material dose level that has a mutation frequency value that is greater than the corresponding vehicle control by the GEF of 126E-06 will be considered positive. However, if a test material produces a modest increase in mutant frequency, which only marginally exceeds the GEF value and is not reproducible or part of a dose-related response, then it may be considered to have no toxicological significance. Conversely, when a test material induces modest reproducible
increases in the mutation frequencies that do not exceed the GEF value then scientific judgement will be applied. If the reproducible responses are significantly dose-related and include increases in the absolute numbers of mutant colonies then they may be considered to be toxicologically
significant. - Statistics:
- Linear trend analysis.
Results and discussion
Test results
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- 10 mM (1061 µg/mL)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- other: The positive controls caused an increase in mutation frequency, but no clastogenic positive control (e.g., MMS) was used in the absence of S9.
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES:
In the 4-hour exposure groups, both in the absence and presence of metabolic activation (S9), there was evidence of modest reductions in the Relative Suspension Growth (%RSG) of cells treated with the test material when compared to the concurrent vehicle controls. However, a significant reduction in %RSG values of cells treated with test material was observed in the 24-hour exposure group in the absence of S9. No precipitate of the test material was observed at any of the dose levels. In the subsequent mutagenicity test the maximum dose level used was the 10 mM limit dose for the 4-hour exposure groups. However, for the 24-hour exposure group, the maximum dose level was limited by test material induced toxicity.
COMPARISON WITH HISTORICAL CONTROL DATA: controls were within historical reference range
Any other information on results incl. tables
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 the
activity of the metabolizing 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,
using a dose range that included the 10 mM dose in the
4-hour exposure groups and also a dose level that induced
the optimum level of toxicity in the 24-hour exposure group.
The proportion of small colonies was not increased, indicating non-clastogenicity of the test material.
Table 1: Experiment 1- 4 h exposure - Without Metabolic Activation
Concentration |
Relative Total Growth |
Mutants per 1E+06 cells |
Quotient small / large colonies |
0 |
1.00 |
108.23 |
0.47 |
66.31 |
0.94 |
94.81 |
0.43 |
132.63 |
0.89 |
98.63 |
0.31 |
265.25 |
0.64 |
99.72 |
0.26 |
530.5 |
0.52 |
81.07 |
0.43 |
795.75 |
0.53 |
64.61 |
0.26 |
1061 |
0.49 |
90.63 |
0.40 |
EMS, 400 |
0.36 |
903.71 |
0.47 |
EMS: Ethyl methane sulphonate
Table 2: Experiment 1- 4 h exposure - With Metabolic Activation
Concentration |
Relative Total Growth |
Mutants per 1E+06 cells |
Quotient small / large colonies |
0 |
1.00 |
95.59 |
0.44 |
66.31 |
0.82 |
107.45 |
0.33 |
132.63 |
0.78 |
97.39 |
0.38 |
265.25 |
0.67 |
72.72 |
0.37 |
530.5 |
0.75 |
86.28 |
0.33 |
795.75 |
0.76 |
110.04 |
0.37 |
1061 |
0.80 |
112.26 |
0.39 |
CP, 2 |
0.23 |
941.38 |
0.77 |
CP: cyclophosphamide
Table 3: Experiment 2 - 24 h exposure - Without Metabolic Activation
Concentration |
Relative Total Growth |
Mutants per 1E+06 cells |
Quotient small / large colonies |
0 |
1.00 |
102.67 |
0.28 |
16.5 |
1.54 |
65.04 |
0.31 |
33 |
1.26 |
91.52 |
0.21 |
66 |
1.15 |
76.53 |
0.22 |
99 |
0.94 |
78.61 |
0.27 |
132 |
0.34 |
105.28 |
0.14 |
198 |
0.11 |
89.77 |
0.15 |
EMS, 150 |
0.34 |
788.05 |
0.27 |
EMS: Ethyl methane sulphonate
Table 4: Experiment 2 - 24 h Exposure - With Metabolic Activation
Concentration |
Relative Total Growth |
Mutants per 1E+06 cells |
Quotient large / small colonies |
0 |
1.00 |
95.61 |
0.21 |
66.31 |
0.94 |
94.73 |
0.29 |
132.63 |
0.70 |
100.86 |
0.21 |
265.25 |
0.57 |
84.05 |
0.17 |
530.5 |
0.54 |
95.55 |
0.25 |
795.75 |
0.49 |
71.98 |
0.27 |
1061 |
0.53 |
114.54 |
0.24 |
CP, 2 |
0.24 |
480.62 |
0.60 |
CP: cyclophosphamide
Applicant's summary and conclusion
- Conclusions:
- MPA was non-mutagenic to L5178Y cells under the conditions of the test. The proportion of small colonies was not increased, indicating non-clastogenicity of the test material.
- Executive summary:
The mutagenic potential of 3-MPA was investigated in a mouse lymphoma assay according to OECD TG 476 (TK assay). Two independent experiments were performed. In Experiment 1, L5178Y TK +/- 3.7.2¢ mouse lymphoma cells (heterozygous at the thymidine kinase locus) were treated with the test material at six 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 eight 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 66.31 to 1061 ug/ml in both the absence and presence of metabolic activation for the first experiment. For the second experiment the dose range was 8.25 to 264 ug/ml in the absence of
metabolic activation and 66.31 to 1061 ug/ml in the presence of metabolic activation.The maximum dose level used was the 10 mM limit dose for the 4-hour exposure groups. However, for the 24-hour exposure group, the maximum dose level was limited by test material induced toxicity. No precipitate of test material was observed at any of the dose levels.
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, using a dose range that included the 10 mM limit dose in the 4-hour exposure groups and also a dose level that induced the optimum level of toxicity in the 24-hour exposure group.
The test material was considered to be non-mutagenic to L5178Y cells under the conditions of the test.
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