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EC number: 246-562-2 | CAS number: 25013-15-4
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- Ecotoxicological Summary
- Aquatic toxicity
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- Short-term toxicity to fish
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- Toxicological Summary
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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:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Similar to OECD 490 and GLP compliant
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 490 (In Vitro Mammalian Cell Gene Mutation Tests Using the Thymidine Kinase Gene)
- GLP compliance:
- yes
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- Vinyltoluene
- EC Number:
- 246-562-2
- EC Name:
- Vinyltoluene
- Cas Number:
- 25013-15-4
- Molecular formula:
- C9H10
- IUPAC Name:
- Reaction mass of 3-methylstyrene and 4-methylstyrene
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Vinyl toluene (Radian Corporation (Austin, TX))
- Physical state: liquid
- Analytical purity: approx. 99%
- Composition of test material, percentage of components: p-Vinyl toluene and m-vinyl toluene represented 31.6% and 68.4%, respectively, of the mixture
- Lot/batch No.:CH910
- Stability under test conditions: Results ofperiodic analysis by infrared spectroscopy, gas chromatography, determination of inhibitor concentration, and polymer concentration indicated no significant degradation of the study material throughout the studies.
- Storage condition of test material: Stability studies performed by gas chromatography indicated that vinyl toluene was stable as a bulk chemical when stored protected from light for 2 weeks at temperatures up to 25° C.
Refer to Appendix G and Table G1 for more details on specific chemical characterisation of the vinyl toluene used in the study.
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Vinyl toluene (Radian Corporation (Austin, TX))
- Physical state: liquid
- Analytical purity: approx. 99%
- Composition of test material, percentage of components: p-Vinyl toluene and m-vinyl toluene represented 31.6% and 68.4%, respectively, of the mixture
- Lot/batch No.:CH910
- Stability under test conditions: Results ofperiodic analysis by infrared spectroscopy, gas chromatography, determination of inhibitor concentration, and polymer concentration indicated no significant degradation of the study material throughout the studies.
- Storage condition of test material: Stability studies performed by gas chromatography indicated that vinyl toluene was stable as a bulk chemical when stored protected from light for 2 weeks at temperatures up to 25° C.
Refer to Appendix G and Table G1 for more details on specific chemical characterisation of the vinyl toluene used in the study.
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:Fischer's medium supplemented with 2 mM L-glutamine, 110 pg/ml sodium pyruvate, 0.05% pluronic F68, antibiotics, and heat-inactivated horse serum. Normal cycling time was about 10 hours.
- Properly maintained: yes
- Periodically "cleansed" against high spontaneous background: Yes; subcultures were exposed once to medium containing thymidine, hypoxanthine, methotrexate, and glycine for 1 day, to thymidine, hypoxanthine, and glycine for 1 day, and to normal medium for 3-5 days.
- Metabolic activation:
- without
- Test concentrations with justification for top dose:
- Trial 1: 12.5, 25, 50, 100 µg/mL
Trial 2: 10, 20, 40, 60, 80 µg/mL
Trial 3: 40, 45, 50, 55, 60, 65 µg/mL - Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- Methyl methanesulfonate:15 µg/mL
- Details on test system and experimental conditions:
- The highest dose of the study compound was determined by solubility or toxicity and did not exceed 100 ug/ml. All doses within an experiment, including concurrent positive and solvent controls, were replicated. Treated cultures contained 6 X 106 cells in 10 ml of medium. Incubation with the study chemical continued for 4 hours, after which time the medium plus chemical was removed and the cells were re-suspended in 20 ml of fresh medium and incubated for an additional 2 days to express the mutant phenotype. Cell density was monitored so that log phase growth was maintained. After the 48-hour expression period, 3 X 106 cells were plated in medium and soft agar supplemented with Tft for selection of Tft-resistant cells (TK +/+),and 600 cells were plated in nonselective medium and soft agar to determine cloning efficiency. Plates were incubated at 37° C under 5% carbon dioxide for 10-12 days.
Replicates: Mean ± standard error from replicate trials of approximately 1 X 106 cells each.
Trials 2 & 3: See table H2 (e) Data presented are the results of four tests; (f) Data presented are the results of three tests. - Evaluation criteria:
- Mutant fraction (frequency) is a ratio of the Tft-resistant cells to the cloning efficiency, divided by 3 (to arrive at MF per 1 X 106 cells treated);
MF = mutant fraction.
Significant positive response occurs when the relative mutant fraction (average MF of treated culture/average MF of solvent control) is greater than or equal to 1.6.
Both responses must be significantly (P< 0.05) positive for a chemical to be considered capable of inducing Tft resistance. If only one of these responses is significant, the call is "equivocal"; the absence of both trend and peak response results in a "negative" call. - Statistics:
- Mean ± standard error from replicate trials of approximately 1 X 106 cells each. All data are evaluated statistically for both trend and peak response
Results and discussion
Test results
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 100 ug/mL
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- In the mouse lymphoma assay in L5178Y cells, vinyl toluene was not mutagenic.
- Executive summary:
In a mammalian cell gene mutation assay (similar to OECD 490/GLP), mouse lymphoma L5178Y cells cultured in vitro were exposed to vinyl toluene (approx. 99%; p-Vinyl toluene (31.6%) and m-vinyl toluene (68.4%)) in DMSO in 3 trials at concentrations of 12.5, 25, 50, 100 µg/mL; 10, 20, 40, 60, 80 µg/mL and 40, 45, 50, 55, 60, 65 µg/mL without metabolic activation.
In the first trial, the highest non-lethal concentration of vinyl toluene was 50 µg /mL. At this level there was no increase in mutant fraction, but the Relative Total Growth (RTG) remained high (69% ±7%). The remaining two experiments gave statistically significant responses at 60 µg /mL. This was the only significant dose level, even marginally lower doses (e.g., 55 µg g/mL) inducing considerably less toxicity and no significant increases in mutant fraction. The Relative Total Growth was below 10% at 60 µg /mL in both experiments (experiment 2: 5.5±0.5% and experiment 3: 8±1.0%). According to paragraph 67 of OECD 490 “If the maximum concentration is based on cytotoxicity, the highest concentration should aim to achieve between 20 and 10% RTG. The consensus is that care should be taken when interpreting positive results only found between 20 and 10% RTG and a result would not be considered positive if the increase in MF occurred only at or below 10% RTG (if evaluated).” Therefore, the mutagenic effects at 60 µg /mL in experiments 2 and 3 cannot be treated as positive results. The top dose with no cytotoxicity data in the first experiment is 50µg /mL, and there is no increase in mutant frequency compared to controls, therefore the substance is not mutagenic.
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