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EC number: 239-491-3 | CAS number: 15471-17-7
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Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / micronucleus study
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 487 - In Vitro Micronucleus Test
- Deviations:
- yes
- Remarks:
- expression phase and harvest time were slightly modified - this deviations are not considered to influence the outcome of the study
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hess. Ministerium für Umwelt, Energie, Landwirtschaft udn Verbraucherschutz, Wiesbaden, Germany
- Type of assay:
- in vitro mammalian cell micronucleus test
Test material
- Reference substance name:
- 1-(3-sulphonatopropyl)pyridinium
- EC Number:
- 239-491-3
- EC Name:
- 1-(3-sulphonatopropyl)pyridinium
- Cas Number:
- 15471-17-7
- Molecular formula:
- C8H11NO3S
- IUPAC Name:
- 1-(2-hydroxy-3-sulphonatopropyl)pyridinium
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): 1-(3-sulphonatopropyl)pyridinium
- Substance type: organic
- Physical state: white powder
- Analytical purity: > 99 % weight - %
- Storage condition of test material: at room temperature
- Other: solubility in water: approximately 1500 g/L
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- lymphocytes: human lymphocytes
- Details on mammalian cell type (if applicable):
- Blood samples were obtained from healthy, non-smoking donors not receiving medication. For this study, blood was collected from a female donor (23 years old) for the first experiment and from a 33 year-old female donor for Experiment II. All donors had a previously established low incidence of micronuclei in their peripheral blood lymphocytes. Blood samples were drawn by venous puncture and collected in heparinized tubes. The tubes were sent to Harlan CCR to initiate cell cultures within 24 hrs after blood collection. If necessary, the blood was stored before use at 4 °C.
- Metabolic activation:
- with and without
- Metabolic activation system:
- liver S9 mix from phenobarbital/beta-naphthoflavone treated male rats
- Test concentrations with justification for top dose:
- 657.3 µg/mL, 1150.3 µg/mL and 2013 µg/mL
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: deionised water, the final concentration of deinonised water in the culture medium was 10 % (v/v)
- Justification for choice of solvent/vehicle: The solvent was chosen due to its solubility properties and its relative non-toxicity to the cell cultures. The solubility of the test item in the solvent is approximately 1500 g/L.
Controls
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Concurrent solvent controls (culture medium with 10 % deionised water) (local tap water deionised at Harlan CCR)).
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- mitomycin C
- other: demecolcin
- Remarks:
- Dilutions of stock solutions were prepared on the day of the experiment. Stability of Demecolcin, Mitomycin C and CPA in solution is unknown but a mutagenic response in the expected range is sufficient biological evidence of chemical stability.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Preincubation period: 40 hours
- Exposure duration: 4 and 20 hours
SPINDLE INHIBITOR (cytogenetic assays): cytochalasin B
STAIN (for cytogenetic assays): Giemsa
NUMBER OF CELLS EVALUATED: at least 1000 binuecleate cells per culture
DETERMINATION OF CYTOTOXICITY
- Method: other: To describe a cytotoxic effect the CBPI (cytokinesis-block proliferation index) was determined in approximately 500 cells per culture and cytotoxicity is expressed as % cytostasis. A CBPI of 1 (all cells are mononucleate) is equivalent to 100 % cytostasis (7). - Evaluation criteria:
- The micronucleus assay is considered acceptable if it meets the following criteria:
a) The number of micronuclei found in the negative and solvent controls falls within the range of the laboratory historical control data.
b) The positive control substances should produce significant increases in the number of cells with micronuclei.
Evaluation of Results
A test item can be classified as non-mutagenic if:
- the number of micronucleated cells in all evaluated dose groups is in the range of the laboratory historical control data and/or
- no statistically significant or concentration-related increase in the number of micronucleated cells is observed.
A test item can be classified as mutagenic if:
- the number of micronucleated cells is not in the range of the historical laboratory control data and
- either a concentration-related increase of micronucleated cells in three test groups or a statistically significant increase of the number of micronucleated cells is observed. - Statistics:
- Statistical significance was confirmed by means of the Chi square test. However, both biological and statistical significance should be considered together. If the criteria for the test item mentioned above are not clearly met, the classification with regard to the historical data and the biological relevance is discussed and/or a confirmatory experiment is performed.
Results and discussion
Test results
- Species / strain:
- lymphocytes: human lymphocytes
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: No relevant influence on osmolarity or pH value was observed.
- Effects of osmolality: No relevant influence on osmolarity or pH value was observed.
- Water solubility: 1500 g/L
- Precipitation: no precipitation of the test item in the pre-test nor in the actual experiments
RANGE-FINDING/SCREENING STUDIES:
With respect to the molecular weight of the test item, 2013.0 µg/mL of 1-(3-sulphonatopropyl) pyridinium (approx. 10 mM) was applied as top concentration for treatment of the cultures in the pre-test. Test item concentrations between 13.1 and 2013.0 µg/mL (with and without S9 mix) were chosen for the evaluation of cytotoxicity. In the pre-test on toxicity, no precipitation of the test item was observed at the end of treatment. Since the cultures fulfilled the requirements for cytogenetic evaluation, this preliminary test was designated Experiment I.
COMPARISON WITH HISTORICAL CONTROL DATA: yes, no confounding factors observed - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
The test item 1-(3-sulphonatopropyl)pyridinium, dissolved in deionised water, was assessed for its potential to induce micronuclei in human lymphocytes in vitro in the absence and presence of metabolic activation by S9 mix. The occurrence of micronuclei in interphase cells provides an indirect but easy and rapid measure of chromosomal damage and aneugenicity. Micronuclei arise from chromosomal fragments or whole chromosomes. Micronuclei rarely occur spontaneously but are inducible by clastogens or agents affecting the spindle apparatus.
Two independent experiments were performed. In Experiment I, the exposure period was 4 hours with and without S9 mix. In Experiment II, the exposure periods were 4 hours with S9 mix and 20 hours without S9 mix. The cells were prepared 40 hours after start of treatment with the test item.
In each experimental group two parallel cultures were analysed. 1000 binucleate cells per culture were scored for cytogenetic damage on coded slides. To determine a cytotoxic effect the CBPI was determined in approximately 500 cells per culture and cytotoxicity is described as % cytostasis.
The highest treatment concentration in this study, 2013.0 µg/mL (approx. 10 mM) was chosen with regard to the molecular weight of the test item and with respect to the OECD Guideline 487 for the in vitro mammalian cell micronucleus test.
No precipitation of the test item in the culture medium was observed at the end of treatment. No relevant influence on osmolarity or pH value was observed.
In this study, at both preparation intervals, in the absence as well as in the presence of S9 mix, no biologically relevant cytotoxicity indicated by a clearly CBPI expressed as cytostasis could be observed (Table 4 and 5).
In both experiments, in the absence and presence of S9 mix, no biologically relevant increase in the number of cells carrying micronuclei was observed (see Table 6, 7, 8 and 9). The micronucleus rates of the cells after treatment with the test item (0.10 - 0.75 % micronucleated cells) were close to the range of the solvent control values (0.15 - 0.35 % micronucleated cells) and within the range of the laboratory historical control data. However, statistically significant increases were observed in Experiment I and II in the presence of S9 mix after treatment with 2013.0 µg/mL (0.70, 0.75 % micronucleated cells, respectively). The values are clearly within the range of the historical control data (0.20 - 1.70 % micronucleated cells) and therefore regarded as biologically irrelevant.
In both experiments, either Demecolcin (75.0 ng/mL), MMC (2.0 µg/mL) or CPA (10.0 or 15.0 µg/mL) were used as positive controls and showed distinct increases in cells with micronuclei.
In conclusion, it can be stated that under the experimental conditions reported, the test item 1-(3-sulphonatopropyl)pyridinium did not induce micronuclei in human lymphocytesin vitrowhen tested up to the highest required concentration.
Table 3a: Summary of results of the in vitro micronucleus test in human lymphocytes with 1-(3-sulphonatopropyl)pyridinium
Exp. |
Preparation |
Test item |
Proliferation |
Cytostasis |
Micronucleated |
|
interval |
concentration |
index |
in %* |
cells |
|
|
in µg/mL |
CBPI |
|
in %** |
Exposure period 4 hrs without S9 mix |
|||||
I |
40 hrs |
Negative control |
1.86 |
|
0.45 |
|
|
Solvent control1 |
1.84 |
|
0.30 |
|
|
Positive control2 |
1.67 |
22.4 |
9.20S |
|
|
657.3 |
1.81 |
4.2 |
0.30 |
|
|
1150.3 |
1.82 |
2.6 |
0.30 |
|
|
2013.0 |
1.73 |
13.6 |
0.20 |
Exposure period 20 hrs without S9 mix |
|||||
II |
40 hrs |
Negative control |
1.92 |
|
0.25 / 0.40*** |
|
|
Solvent control1 |
1.92 |
|
0.35 |
|
|
Positive control3 |
1.71 |
23.2 |
2.60S/3.00S*** |
|
|
657.3 |
1.89 |
2.7 |
0.30 |
|
|
1150.3 |
1.82 |
10.5 |
0.15 |
|
|
2013.0 |
1.87 |
5.0 |
0.20 |
* For the positive control groups, the relative values are related to the negative controls; for the test item treatment groups are related to the solvent controls.
** The number of micronucleated cells was determined in a sample of 2000 binucleated cells
*** The number of micronucleated cells was determined in a sample of 2000 mononucleated cells
S The number of micronucleated cells is statistically significantly higher than corresponding control values
1 Deionised
water 10.0 % (v/v)
2 MMC 2.0
µg/mL
3 Demecolcin75.0 ng/mL
Table 3b: continued Summary of results of the in vitro micronucleus test in human lymphocytes with 1-(3-sulphonatopropyl)pyridinium
Exp. |
Preparation |
Test item |
Proliferation |
Cytostasis |
Micronucleated |
|
interval |
concentration |
index |
in %* |
cells |
|
|
in µg/mL |
CBPI |
|
in %** |
Exposure period 4 hrs with S9 mix |
|||||
I |
40 hrs |
Negative control |
1.69 |
|
0.30 |
|
|
Solvent control1 |
1.78 |
|
0.15 |
|
|
Positive control2 |
1.37 |
46.2 |
2.40S |
|
|
657.3 |
1.69 |
10.9 |
0.45 |
|
|
1150.3 |
1.72 |
8.2 |
0.50 |
|
|
2013.0 |
1.77 |
0.8 |
0.70S |
II |
40 hrs |
Negative control |
1.57 |
|
0.40 |
|
|
Solvent control1 |
1.60 |
|
0.25 |
|
|
Positive control3 |
1.48 |
16.5 |
2.80S |
|
|
657.3 |
1.56 |
6.2 |
0.10 |
|
|
1150.3 |
1.60 |
0.3 |
0.30 |
|
|
2013.0 |
1.57 |
4.8 |
0.75S |
* For the positive control groups,
the relative values are related to the negative controls;
for the test item treatment groups the values are related to the solvent
controls
** The number of micronucleated cells was determined in a sample of 2000 binucleated cells
S The number of micronucleated cells is statistically significantly higher than corresponding control values
1 Deionised
water 10.0 % (v/v)
2 CPA 15.0
µg/mL
3 CPA 10.0 µg/mL
Table 4: Cytotoxicity of 1-(3-sulphonatopropyl)pyridinium to the cultures of human lymphocytes (experiment 1).
Concentration |
Exposure time |
Preparation interval |
CBPI |
Cytostasis (%) |
Without S9 mix |
||||
Negative control |
4 hrs |
40 hrs |
1.86 |
--- |
Solvent control |
4 hrs |
40 hrs |
1.84 |
--- |
13.1 |
4 hrs |
40 hrs |
n.d. |
n.d. |
22.9 |
4 hrs |
40 hrs |
n.d. |
n.d. |
40.0 |
4 hrs |
40 hrs |
n.d. |
n.d. |
70.1 |
4 hrs |
40 hrs |
n.d. |
n.d. |
122.6 |
4 hrs |
40 hrs |
1.79 |
5.9 |
214.6 |
4 hrs |
40 hrs |
1.77 |
8.6 |
375.6 |
4 hrs |
40 hrs |
1.75 |
11.1 |
657.3 |
4 hrs |
40 hrs |
1.81 |
4.2 |
1150.3 |
4 hrs |
40 hrs |
1.82 |
2.6 |
2013.0 |
4 hrs |
40 hrs |
1.73 |
13.6 |
With S9 mix |
||||
Negative control |
4 hrs |
40 hrs |
1.69 |
--- |
Solvent control |
4 hrs |
40 hrs |
1.78 |
--- |
13.1 |
4 hrs |
40 hrs |
n.d. |
n.d. |
22.9 |
4 hrs |
40 hrs |
n.d. |
n.d. |
40.0 |
4 hrs |
40 hrs |
n.d. |
n.d. |
70.1 |
4 hrs |
40 hrs |
n.d. |
n.d. |
122.6 |
4 hrs |
40 hrs |
1.72 |
7.2 |
214.6 |
4 hrs |
40 hrs |
1.72 |
8.0 |
375.6 |
4 hrs |
40 hrs |
1.76 |
2.1 |
657.3 |
4 hrs |
40 hrs |
1.69 |
10.9 |
1150.3 |
4 hrs |
40 hrs |
1.72 |
8.2 |
2013.0 |
4 hrs |
40 hrs |
1.77 |
0.8 |
* Mean value of two cultures
n.d. Not determined
Table 5: Cytotoxicity of 1-(3-sulphonatopropyl)pyridinium to the cultures of human lymphocytes (experiment 2).
Concentration |
Exposure time |
Preparation interval |
CBPI |
Cytostasis (%) |
Without S9 mix |
||||
Negative control |
20 hrs |
40 hrs |
1.92 |
--- |
Solvent control |
20 hrs |
40 hrs |
1.92 |
--- |
13.1 |
20 hrs |
40 hrs |
n.d. |
n.d. |
22.9 |
20 hrs |
40 hrs |
n.d. |
n.d. |
40.0 |
20 hrs |
40 hrs |
n.d. |
n.d. |
70.1 |
20 hrs |
40 hrs |
n.d. |
n.d. |
122.6 |
20 hrs |
40 hrs |
1.80 |
12.4 |
214.6 |
20 hrs |
40 hrs |
1.87 |
5.2 |
375.6 |
20 hrs |
40 hrs |
1.85 |
7.3 |
657.3 |
20 hrs |
40 hrs |
1.89 |
2.7 |
1150.3 |
20 hrs |
40 hrs |
1.82 |
10.5 |
2013.0 |
20 hrs |
40 hrs |
1.87 |
5.0 |
With S9 mix |
||||
Negative control |
4 hrs |
40 hrs |
1.57 |
--- |
Solvent control |
4 hrs |
40 hrs |
1.60 |
--- |
214.6 |
4 hrs |
40 hrs |
1.57 |
4.5 |
375.6 |
4 hrs |
40 hrs |
1.63 |
n.c. |
657.3 |
4 hrs |
40 hrs |
1.56 |
6.2 |
1150.3 |
4 hrs |
40 hrs |
1.60 |
0.3 |
2013.0 |
4 hrs |
40 hrs |
1.57 |
4.8 |
Experimental groups evaluated for
cytogenetic damage are shown in bold characters
* Mean value of two cultures
n.d.Not determined
n.c. Not calculated as the CBPI is equal or higher than the solvent
control value
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative without metabolic activation
negative with metabolic activation
The study was performed according to the OECD Guideline 487 with deviations (expression phase and harvest time were slightly modified - these deviations are not considered to influence the outcome of the study) and is considered to be of the highest quality (reliability Klimisch 1). The vehicle water and the positive control substances fulfilled validity criteria of the test system. The positive controls mitomycin C, demecolcin and cyclophosphamide induced micronuclei and demonstrated the sensitivity of the test system and the activity of the used S9 mix. None of the cultures treated with 1-(3-sulphonatopropyl)pyridinium in the absence and in the presence of S9 mix showed biologically relevant or statistically significant increased numbers of micronuclei. Based on this test, 1-(3-sulphonatopropyl)pyridinium is considered not to be non-mutagenic in human lymphocytes. - Executive summary:
The test item 1-(3-sulphonatopropyl)pyridinium, dissolved in deionised water, was assessed for its potential to induce micronuclei in human lymphocytes in vitro (Bohnenberger, 2012). Cultured human lymphcytes were used and the following study design was performed: experiment 1without S9 -mix (exposure period 4 hrs, recovery 16 hours, Cytochalason B exposure 20 hours, preparation interval 40 hours, total culture period 88 hours), experiment 2 without S9 -mix (exposure period 20 hrs, Cytochalason B exposure 20 hours, preparation interval 40 hours, total culture period 88 hours), experiment 1 and b with S9 -mix (exposure period 4 hrs, recovery 16 hours, Cytochalason B exposure 20 hours, preparation interval 40 hours, total culture period 88 hours). In each experimental group two parallel cultures were analysed. 1000 binucleate cells per culture were scored for cytogenic damage on coded slides. The highest applied concentration in the pre-test on toxicity (2013.0 µg/mL of the test item, approx. 10 mM) was chosen with regard to the molecular weight of the test item and with respect to the current OECD Guideline 487. Dose selection of the cytogenetic experiment was performed considering the toxicity data in accordance with OECD Guideline 487. In the absence and presence of S9 mix, no cytotoxicity was observed up to the highest applied concentration. In the absence and the presence of S9 mix, no increase in the number of micronucleated cells was observed after treatment with the test item. However, statistically significant increases were observed in Experiment I and II in the presence of S9 mix after treatment with 2013.0 µg/mL (0.70, 0.75 % micronucleated cells, respectively). The values are clearly within the range of the historical control data (0.20 - 1.70 % micronucleated cells) and therefore regarded as biologically irrelevant. Appropriate mutagens were used as positive controls. The positive controls mitomycin C, demecolcin and cyclophosphamide induced statistically significant increases in cells with micronuclei and demonstrated the sensitivity of the test system and the activity of the used S9 mix. .
In conclusion, it can be stated that under the experimental conditions reported, the test item did not induce micronuclei as determined by the in vitro micronucleus test in human lymphocytes. Therefore, 1-(3-sulphonatopropyl)pyridinium is considered to be non-mutagenic in this in vitro micronucleus test, when tested up to the highest required concentration.
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