Registration Dossier
Registration Dossier
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EC number: 911-168-8 | CAS number: -
Specific investigations: other studies
Administrative data
Link to relevant study record(s)
- Endpoint:
- cytotoxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From February 25 to April 01, 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Qualifier:
- according to guideline
- Guideline:
- other: ISO10993, published by the International Organization for Standardization: "Biological Evaluation of Medical Devices" Part 5, Chapter 8.2, 1992 and Part 12, 1996
- Qualifier:
- according to guideline
- Guideline:
- other: USP 25-NF20 supplement 2 "Biological Reactivity Tests, in vitro" Chapter 87, 2002; does not include the "USP Negative Control Plastic Reference Standard" and "USP Positive Bioreaction Extract Reference Standard" because these Standards are not available.
- Qualifier:
- according to guideline
- Guideline:
- other: prEN 7405: 1995 (5.2.1.c) "Präklinische Beurteilung der Gewebeverträglichkeit von Medizinprodukten in der Zahnheilkunde-Prüfuerfahren"
- Qualifier:
- according to guideline
- Guideline:
- other: Guide to Medical Device Registration in Japan, 4 ed., 1992, Appendix 3. Publisher Yakui Nippon Ltd. Tokyo, Japan.
- Principles of method if other than guideline:
- The study was performed to assess the cytotoxicity potential of the test item by means of the cytotoxicity in vitro test for soluble test items. The test was carried out with the mouse cell line L929.
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- in vitro
- Endpoint addressed:
- other: cytotoxicity
- Species:
- mouse
- Details on test animals or test system and environmental conditions:
- - Cell line: mouse cell line L929
- Reasons for the Choice of the Cell Line: the ATCC, CCL 1 NCTC clone 929 (clone of strain L, mouse connective tissue) cell line has been used for many years in in vitro experiments with success. Especially the high and established proliferation time rate (doubling time: 16 h) and a good viability of untreated cells (as a rule more than 70 %), both necessary for the appropriate performance of the study, recommend the use of this cell line.
- Supplier: LMP, Technical University Darmstadt, D-64287 Darmstad.
- Storage: large stocks of the L929 cell line were stored in liquid nitrogen in the cell bank of testing laboratory allowing the repeated use of the same cell culture batch in experiments.
- Propagation: thawed stock cultures were propagated at 37 °C in plastic flasks.
- Seeding: seeding was done with about 2 x 10^5 cells per flask in 6 ml of RPMI 1640 supplemented with 10 % fetal calf serum (FKS).
- Subculturing: the cells were subcultured twice weekly.
- Incubation: the cell cultures were incubated at 37 °C and 4.5 % carbon dioxide atmosphere. - Vehicle:
- DMSO
- Details on exposure:
- On the day of the experiment, the test item was suspended with DMSO. The final concentration of DMSO did not exceed 1.0 % (v/v) in the culture medium (RPMI-medium with 10 % FCS).
- Remarks:
- 39.1, 78.1, 156.3, 312.5, 625, 1250, 2500 and 5000 µg/ml
- Control animals:
- yes, concurrent no treatment
- yes, concurrent vehicle
- Details on study design:
- SEEDING OF THE CULTURES
Exponentially growing stock cultures more than 50 % confluent were rinsed with Ca-Mg-free salt solution and treated with Trypsin at 37 °C for 5 minutes. Then the enzymatic digestion was stopped by adding complete culture medium and a single cell suspension was prepared.
The Ca-Mg-free salt solution was composed as follows (per litre): NaCl 8000 mg, KCI 400 mg, Glucose 1000 mg and NaHCO3 350 mg.
Individual wells of 96-well tissue-culture microtitre plates (Greiner) were inoculated with 0.1 ml medium containing 1073 cells. The medium was RPMI 1640 + 10 % FCS (complete medium). The plates were incubated for 24 hours to enable cellular attachment.
TREATMENT
The medium was removed and the cells were re-fed with 0.1 ml treatment medium containing different concentrations of the test item, negative, solvent, and positive control, respectively. All incubations were done at 37 °C in a humidified atmosphere with 4.5 ± 0.5 % CO2.
After an incubation period of 8 h, 3HTdR (5 µCi/ml culture medium, specific activity 20 Ci/mmol) was added to each well. The cells were incubated for further 16 h. Subsequently, the cells were harvested using a 12 well cell harvester and one filter per culture. The filters were washed with deionised water. The filters were dried (at approx. 100 °C) overnight. Each filter was placed in a vial containing 3 ml rotiszint eco plus solution. The amount of 3HTdR on the filter was measured using a LKB Wallac 1219 Rackbeta Liquid Scintillation Counter. - Examinations:
- Decrease in number of living cells results in a decrease of 3HTdR incorporated in the cells. The decrease directly correlates to the amount of 3HTdR measured as scintillation counts.
- Positive control:
- Sodium dodecylsulfate (purity > 99 %).
The positive control was tested in 8 concentrations in a range from 2.5 - 25 µg/ml and was applied 7 times. - Details on results:
- EC50-value: could not be determined as viability was not reduced below 50 % of solvent control.
- Conclusions:
- The test item does not possess any cytotoxic potential.
- Executive summary:
The in vitro study was performed to assess the cytotoxic potential of test item by means of the XTT test using the mouse cell line L929. The following concentrations of the test item were tested: 39.1, 78.1, 156.3, 312.5, 625, 1250, 2500 and 5000 µg/ml.
Culture medium (RPMI containing 10 % (v/v) FCS) was used as negative control. The solvent control was RPMI medium containing 10 % (v/v) FCS and 1.0 % DMSO. SDS was used as positive control.
The incubation time was 24 hours at 37 °C.
The negative control and the solvent control showed no relevant reduction in cell viability and cell proliferation.
The positive control (SDS) induced a distinct dose-related reduction in cell viability and cell proliferation. The calculated EC50 value is 11.8 µg/ml.
At the highest concentration of 250 µg/ml viability was reduced to 0.4 % of the solvent control.
No relevant cytotoxic effects were observed following incubation with test item up to the highest tested concentration (5000 µg/ml). A slight reduction at a concentration of 625 µg/ml only, can be considered as not relevant, since the viability was more than 100 % at higher concentrations. Due to the lack of cytotoxicity, no EC50 values could be calculated.
Conclusion
In conclusion, it can be stated that under the experimental conditions reported, the test item does not possess any cytotoxic potential.
- Endpoint:
- cytotoxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From November 05 to December 12, 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Qualifier:
- according to guideline
- Guideline:
- other: ISO10993, published by the International Organization for Standardization: "Biological Evaluation of Medical Devices" Part 5, Chapter 8.2, 1992 and Part 12, 1996
- Qualifier:
- according to guideline
- Guideline:
- other: USP 25-NF20 supplement 2 "Biological Reactivity Tests, in vitro" Chapter 87, 2002; does not include the "USP Negative Control Plastic Reference Standard" and "USP Positive Bioreaction Extract Reference Standard" because these Standards are not available.
- Principles of method if other than guideline:
- The study was performed to assess the cytotoxicity potential of the test item by means of the cytotoxicity in vitro test for soluble test items. The test was carried out with the mouse cell line L929.
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- in vitro
- Endpoint addressed:
- other: cytotoxicity
- Species:
- mouse
- Details on test animals or test system and environmental conditions:
- - Cell line: mouse cell line L929
- Reasons for the Choice of the Cell Line: the ATCC, CCL 1 NCTC clone 929 (clone of strain L, mouse connective tissue) cell line has been used for many years in in vitro experiments with success. Especially the high and established proliferation time rate (doubling time: 16 h) and a good viability of untreated cells (as a rule more than 70 %), both necessary for the appropriate performance of the study, recommend the use of this cell line.
- Supplier: LMP, Technical University Darmstadt, D-64287 Darmstad.
- Storage: large stocks of the L929 cell line were stored in liquid nitrogen in the cell bank of testing laboratory allowing the repeated use of the same cell culture batch in experiments.
- Propagation: thawed stock cultures were propagated at 37 °C in plastic flasks.
- Seeding: seeding was done with about 2 × 10^5 cells per flask in 6 ml of RPMI 1640 supplemented with 10 % fetal calf serum (FKS).
- Subculturing: the cells were subcultured twice weekly.
- Incubation: the cell cultures were incubated at 37 °C and 4.5 % carbon dioxide atmosphere. - Vehicle:
- DMSO
- Details on exposure:
- On the day of the experiment, the test item was suspended with DMSO. The final concentration of DMSO did not exceed 1.0 % (v/v) in the culture medium (RPMI-medium with 10 % FCS).
- Remarks:
- plate 1: 0.39, 0.78, 1.56, 3.13, 6.25, 12.5, 25 and 50 µg/ml
- Remarks:
- plate 2: 62.5, 125, 250, 500 and 1000 µg/ml
- Control animals:
- yes, concurrent no treatment
- yes, concurrent vehicle
- Details on study design:
- SEEDING OF THE CULTURES
Exponentially growing stock cultures more than 50 % confluent were rinsed with Ca-Mg-free salt solution and treated with Trypsin at 37 °C for 5 minutes. Then the enzymatic digestion was stopped by adding complete culture medium and a single cell suspension was prepared.
The Ca-Mg-free salt solution was composed as follows (per litre): NaCl 8000 mg, KCI 400 mg, Glucose 1000 mg and NaHCO3 350 mg.
Individual wells of 96-well tissue-culture microtitre plates (Greiner) were inoculated with 0.1 ml medium containing 1230 cells. The medium was RPMI 1640 + 10 % FCS (complete medium). The plates were incubated for 24 hours to enable cellular attachment.
TREATMENT
The medium was removed and the cells were re-fed with 0.1 ml treatment medium containing different concentrations of the test item, negative, solvent, and positive control, respectively. All incubations were done at 37 °C in a humidified atmosphere with 4.5 ± 0.5 % CO2.
After an incubation period of 8 h, 3HTdR (5 µCi/ml culture medium, specific activity 20 Ci/mmol) was added to each well. The cells were incubated for further 16 h. Subsequently, the cells were harvested using a 12- well cell harvester and one filter per culture. The filters were washed with deionised water. The filters were dried (at approx. 100 °C) overnight. Each filter was placed in a vial containing 3 ml rotiszint eco plus solution. The amount of 3HTdR on the filter was measured using a LKB Wallac 1219 Rackbeta Liquid Scintillation Counter. - Examinations:
- Decrease in number of living cells results in a decrease of 3HTdR incorporated in the cells. The decrease directly correlates to the amount of 3HTdR measured as scintillation counts.
- Positive control:
- Sodium dodecylsulfate (purity > 99 %).
The positive control was tested in 8 concentrations in a range from 3.1 - 250 µg/ml and was applied 7 times. - Details on results:
- Plate 1 EC50-value: could not be determined as viability was not reduced below 50 % of solvent control.
Plate 2 EC50-value: could not be determined as viability was not reduced below 50 % of solvent control. - Conclusions:
- The test item does not possess any cytotoxic potential.
- Executive summary:
The in vitro study was performed to assess the cytotoxic potential of test item by means of the XTT test using the mouse cell line L929. The following concentrations of the test item were tested: 0.39, 0.78, 1.56, 3.13, 6.25, 12.5, 25, 50, 62.5, 125, 250, 500, and 1000 µg/ml. At higher concentrations no stable suspension of test item in DMSO could be achieved. Therefore, the test item could not be tested up to 5000 µg/ml.
Culture medium (RPMI containing 10 % (v/v) FCS) was used as negative control. The solvent control was RPMI medium containing 10 % (v/v) FCS and 1.0 % DMSO. SDS was used as positive control.
The incubation time was 24 hours at 37 °C.
The negative control and the solvent control showed no relevant reduction in cell viability and cell proliferation.
The positive control (SDS) induced a distinct dose-related reduction in cell viability and cell proliferation. The calculated EC50 value is 79.0 µg/ml.
At the highest concentration of 250 µg/ml viability was reduced to 0.4 % of the solvent control.
No cytotoxic effects were observed following incubation with test item up to the highest tested concentration (1000 µg/ml). Due to the lack of cytotoxicity, no EC50 value could be calculated.
Conclusion
In conclusion, it can be stated that under the experimental conditions reported, the test item does not possess any cytotoxic potential.
- Endpoint:
- cytotoxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April from 01 to 16, 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Qualifier:
- according to guideline
- Guideline:
- other: ISO10993, published by the International Organization for Standardization: "Biological Evaluation of Medical Devices" Part 5, Chapter 8.2, 1992 and Part 12, 1996
- Qualifier:
- according to guideline
- Guideline:
- other: USP 25-NF20 supplement 2 "Biological Reactivity Tests, in vitro" Chapter 87, 2002; does not include the "USP Negative Control Plastic Reference Standard" and "USP Positive Bioreaction Extract Reference Standard" because these Standards are not available.
- Principles of method if other than guideline:
- The study was performed to assess the cytotoxicity potential of the test item by means of the cytotoxicity in vitro test for soluble test items. The test was carried out with the mouse cell line L929.
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- in vitro
- Endpoint addressed:
- other: cytotoxicity
- Species:
- mouse
- Details on test animals or test system and environmental conditions:
- - Cell line: mouse cell line L929
- Reasons for the Choice of the Cell Line: the ATCC, CCL 1 NCTC clone 929 (clone of strain L, mouse connective tissue) cell line has been used for many years in in vitro experiments with success. Especially the high and established proliferation time rate (doubling time: 16 h) and a good viability of untreated cells (as a rule more than 70 %), both necessary for the appropriate performance of the study, recommend the use of this cell line.
- Supplier: LMP, Technical University Darmstadt, D-64287 Darmstad.
- Storage: large stocks of the L929 cell line were stored in liquid nitrogen in the cell bank of testing laboratory allowing the repeated use of the same cell culture batch in experiments.
- Propagation: thawed stock cultures were propagated at 37 °C in plastic flasks.
- Seeding: seeding was done with about 2 × 10^5 cells per flask in 6 ml of RPMI 1640 supplemented with 10 % fetal calf serum (FKS).
- Subculturing: the cells were subcultured twice weekly.
- Incubation: the cell cultures were incubated at 37 °C and 4.5 % carbon dioxide atmosphere. - Vehicle:
- DMSO
- Details on exposure:
- On the day of the experiment, the test item was suspended with DMSO. The final concentration of DMSO in the culture medium did not exceed 1.0 % (v/v).
- Remarks:
- 7.8, 15.6, 31.25, 62.5, 125, 250, 500 and 1000 µg/ml
- Control animals:
- yes, concurrent no treatment
- yes, concurrent vehicle
- Details on study design:
- SEEDING OF THE CULTURES
Exponentially growing stock cultures more than 50 % confluent were rinsed with Ca-Mg-free salt solution and treated with Trypsin at 37 °C for 5 minutes. Then the enzymatic digestion was stopped by adding complete culture medium and a single cell suspension was prepared.
The Ca-Mg-free salt solution was composed as follows (per litre): NaCl 8000 mg, KCI 400 mg, Glucose 1000 mg and NaHCO3 350 mg.
Individual wells of 96-well tissue-culture microtitre plates (Greiner) were inoculated with 0.1 ml medium containing 1000 cells. The medium was RPMI 1640 + 10 % FCS (complete medium). The plates were incubated for 24 hours to enable cellular attachment.
TREATMENT
The medium was removed and the cells were re-fed with 0.1 ml treatment medium containing different concentrations of the test item, negative, solvent, and positive control, respectively. All incubations were done at 37 °C in a humidified atmosphere with 4.5 ± 0.5 % CO2.
After an incubation period of 8 h, 3HTdR (5 µCi/ml culture medium, specific activity 20 Ci/mmol) was added to each well. The cells were incubated for further 16 h. Subsequently, the cells were harvested using a 12- well cell harvester and one filter per culture. The filters were washed with deionised water. The filters were dried (at approx. 100 °C) overnight. Each filter was placed in a vial containing 3 ml rotiszint eco plus solution. The amount of 3HTdR on the filter was measured using a LKB Wallac 1219 Rackbeta Liquid Scintillation Counter. - Examinations:
- Decrease in number of living cells results in a decrease of 3HTdR incorporated in the cells. The decrease directly correlates to the amount of 3HTdR measured as scintillation counts.
- Positive control:
- Sodium dodecylsulfate (purity > 99 %).
The positive control was tested in 8 concentrations in a range from 3.1 - 250 µg/ml and was applied 7 times. - Details on results:
- EC50-value: could not be determined as viability was not reduced.
- Conclusions:
- The test item does not possess any cytotoxic potential.
- Executive summary:
The in vitro study was performed to assess the cytotoxic potential of test item by means of the XTT test using the mouse cell line L929. The following concentrations of the test item were tested: 7.8, 15.6, 31.25, 62.5, 125, 250, 500, 1000 µg/ml.
Culture medium (RPMI containing 10 % (v/v) FCS) was used as negative control. The solvent control was RPMI medium containing 10 % (v/v) FCS and 1.0 % DMSO. SDS was used as positive control.
The incubation time was 8 hours at 37 °C.
The negative control and the solvent control showed no relevant reduction in cell viability.
The positive control (SDS) induced a distinct dose-related reduction in cell viability and cell proliferation. The calculated EC50 value is 112.8 µg/ml.
No relevant cytotoxic etfects were observed following incubation with test item up to the highest tested concentration (1000 µg/ml). Due to the lack of cytotoxicity, no EC50 values could be calculated.
Conclusion
In conclusion, it can be stated that under the experimental conditions reported, the test item does not possess any cytotoxic potential.
Referenceopen allclose all
Results with test item
| Test group | Concentration in µg/ml | Scintillation counts* | Standard- Deviation | Chem. Blanks | Scintillation counts in % of solvent control** |
| Negative control | 25405.8 | 7652.4 | 345.0 | 111.2 | |
| Solvent control | 22929.1 | 5360.9 | 394.0 | 100.0 | |
| Test item | 39.1 | 25680.9 | 6942.6 | 301.6 | 112.6 |
| Test item | 78.1 | 24735.1 | 6945.9 | 421.8 | 107.9 |
| Test item | 156.3 | 25187.6 | 7733.1 | 560.0 | 109.3 |
| Test item | 312.5 | 22470.5 | 4838.5 | 439.7 | 97.8 |
| Test item | 625.0 | 15246.8 | 3799.8 | 138.2 | 67.0 |
| Test item | 1250.0 | 32587.5 | 4919.5 | 115.2 | 144.1 |
| Test item | 2500.0 | 23288.5 | 5378.7 | 358.1 | 101.8 |
| Test item | 5000.0 | 24206.6 | 4839.9 | 234.0 | 106.4 |
* mean scintillation counts (absolute) of 7 wells
**scintillation counts in % of solvent control: [100 x (cound speciem) / (count speciem solvent control)]
POSITIVE CONTROL
| Test group | Concentration in µg/ml | Scintillation counts* | Standard- Deviation | Chem. Blanks | Scintillation counts in % of solvent control** |
| Negative control | 22619.6 | 10278.6 | 267.5 | 128.7 | |
| Solvent control | 19925.6 | 5627.5 | 2551.9 | 100.0 | |
| SDS | 2.5 | 22435.5 | 9295.5 | 1259.8 | 121.9 |
| SDS | 5.0 | 21564.7 | 4405.1 | 1199.9 | 117.2 |
| SDS | 7.5 | 20842.1 | 4526.2 | 1060.6 | 113.9 |
| SDS | 10.0 | 23253.4 | 12332.5 | 101.0 | 133.3 |
| SDS | 12.5 | 3241.5 | 7177.0 | 114.3 | 18.0 |
| SDS | 15.0 | 540.2 | 565.8 | 285.2 | 1.5 |
| SDS | 20.0 | 378.4 | 442.4 | 132.7 | 1.4 |
| SDS | 25.0 | 21156.7 | 9220.1 | 163.2 | 120.8*** |
* mean scintillation counts (absolute) of 7 wells
**scintillation counts in % of solvent control: [100 x (cound speciem) / (count speciem solvent control)]
*** pipetting error during treatment
EC50-value: 11.8 µg/ml
Results with test item Plate 1
| Test group | Concentration in µg/ml | Scintillation counts* | Standard- Deviation | Scintillation counts in % of solvent control** |
| Negative control | - | 9034.1 | 2000.1 | 70.4 |
| Solvent control | - | 12833.0 | 1431.0 | 100.0 |
| Test item | 0.39 | 13991.1 | 2079.7 | 109.0 |
| Test item | 0.78 | 16359.9 | 2345.0 | 127.5 |
| Test item | 1.56 | 13219.9 | 1773.4 | 103.0 |
| Test item | 3.13 | 14222.1 | 1628.1 | 110.8 |
| Test item | 6.25 | 14158.3 | 1883.1 | 110.3 |
| Test item | 12.5 | 14765.0 | 1352.8 | 115.1 |
| Test item | 25 | 16290.0 | 2965.4 | 126.9 |
| Test item | 50 | 14868.8 | 2020.0 | 115.9 |
Shaded cells represent dose groups where test item precipitation occured
* mean scintillation counts (absolute) of 7 wells
**scintillation counts in % of solvent control: [100 x (cound speciem) / (count speciem solvent control)]
Results with test item Plate 2
| Test group | Concentration in µg/ml | Scintillation counts* | Standard- Deviation | Scintillation counts in % of solvent control** |
| Negative control | - | 6307.1 | 1342.5 | 81.8 |
| Solvent control | - | 7707.3 | 2000.1 | 100.0 |
| Test item | 62.5 | 10951.0 | 1826.3 | 142.1 |
| Test item | 125 | 10001.7 | 1499.1 | 129.8 |
| Test item | 250 | 8511.2 | 1208.3 | 110.4 |
| Test item | 500 | 8271.8 | 1174.4 | 107.3 |
| Test item | 1000 | 6979.4 | 2118.7 | 90.6 |
Shaded cells represent dose groups where test item precipitation occured
* mean scintillation counts (absolute) of 7 wells
**scintillation counts in % of solvent control: [100 x (cound speciem) / (count speciem solvent control)]
POSITIVE CONTROL
| Test group | Concentration in µg/ml | Scintillation counts* | Standard- Deviation | Scintillation counts in % of solvent control** |
| Negative control | - | 7428.5 | 32.7 | 84.6 |
| Solvent control | - | 8783.7 | 3445.9 | 100.0 |
| SDS | 3.13 | 9357.1 | 4446.2 | 106.5 |
| SDS | 6.25 | 9256.3 | 3948.8 | 105.4 |
| SDS | 12.5 | 8162.4 | 3777.8 | 92.9 |
| SDS | 25 | 9455.1 | 5737.1 | 107.6 |
| SDS | 50 | 7005.4 | 3753.4 | 79.8 |
| SDS | 100 | 2495.7 | 1805.5 | 28.4 |
| SDS | 125 | 39.3 | 20.4 | 0.4 |
| SDS | 250 | 34.1 | 17.9 | 0.4 |
* mean scintillation counts (absolute) of 7 wells
**scintillation counts in % of solvent control: [100 x (cound speciem) / (count speciem solvent control)]
EC50-value: 79.0 µg/ml
Results with test item
| Test group | Concentration in µg/ml | Scintillation counts* | Standard- Deviation | Relative scintillation in % of solvent control** |
| Negative control | 8903 | 2005 | 108.4 | |
| Solvent control | 8090 | 941 | 100.0 | |
| Test item | 7.8 | 9103 | 671 | 110.9 |
| Test item | 15.6 | 8428 | 1149 | 102.6 |
| Test item | 31.25 | 7642 | 1324 | 93.1 |
| Test item | 62.5 | 9200 | 966 | 112.0 |
| Test item | 125 | 10552 | 2006 | 128.5 |
| Test item | 250 | 8552 | 665 | 104.1 |
| Test item | 500 | 9509 | 1095 | 115.8 |
| Test item | 1000 | 9346 | 991 | 113.8 |
* mean scintillation counts (absolute) of 7 wells
**scintillation counts in % of solvent control: [100 x (cound speciem) / (count speciem solvent control)]
POSITIVE CONTROL
| Test group | Concentration in µg/ml | Scintillation counts* | Standard- Deviation | Scintillation in % of solvent control** |
| Negative control | 6961 | 1257 | 110.8 | |
| Solvent control | 6284 | 823 | 100.0 | |
| SDS | 3.125 | 6619 | 1071 | 105.3 |
| SDS | 6.25 | 6662 | 881 | 106.0 |
| SDS | 12.5 | 5518 | 825 | 87.8 |
| SDS | 25 | 6785 | 1074 | 108.0 |
| SDS | 50.0 | 7335 | 1548 | 116.7 |
| SDS | 100.0 | 6412 | 2782 | 102.0 |
| SDS | 125.0 | 33 | 9 | 0.5 |
| SDS | 250.0 | 20 | 4 | 0.3 |
* mean scintillation counts (absolute) of 7 wells
**scintillation counts in % of solvent control: [100 x (cound speciem) / (count speciem solvent control)]
EC50-value: 112.8 µg/ml
Description of key information
The test item does not possess any cytotoxic potential.
Additional information
Three in vitro experiments were performed to assess the cytotoxic potential of test item, by means of the XTT test using the mouse cell line L929.
Considering all experiments, the concentrations tested cover a range from 0.39 up to 5000 µg/ml; test item was dissolved in DMSO in one case and in culture medium RPMI in the other two cases. The experiments were performed under comparable conditions. The incubation duration was of 24 hours in two experiments and 8 hours in the third.
In the experiment in which test item was dissolved in DMSO, no cytotoxic effects were observed following incubation up to the highest tested concentration of 1000 µg/ml.
No relevant cytotoxic effects were observed following incubation with test item and RPMI up to 5000 µg/ml; a slight reduction recorded at a concentration of 625 µg/ml only was judged as not relevant, since the viability was more than 100 % at higher concentrations.
Comparable results were obtained in the second experiment conducted with test item dissolved in RPMI culture medium. No relevant cytotoxic effects were observed following incubation up to 1000 µg/ml. Due to the lack of cytotoxicity, no EC50 values could be calculated.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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