Registration Dossier
Registration Dossier
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EC number: 617-879-7 | CAS number: 865536-03-4
Specific investigations: other studies
Administrative data
- Endpoint:
- cytotoxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Guideline ISO 10993, published by the International Organization for Standardization: "Biological Evaluation of Medical Devices" Part 5: "Tests for cytotoxicity: In vitro methods", 1992.
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- in vitro
Test material
- Reference substance name:
- bis(11-methyldodecyl) ((((1,3-phenylenebis(methylene)bis(azanediyl))bis(carbonyl) bis(azanediyl))bis(4-methyl-3,1-phenylene) dicarbamate
- Cas Number:
- 865536-03-4
- Molecular formula:
- C52H80N6O6
- IUPAC Name:
- bis(11-methyldodecyl) ((((1,3-phenylenebis(methylene)bis(azanediyl))bis(carbonyl) bis(azanediyl))bis(4-methyl-3,1-phenylene) dicarbamate
- Reference substance name:
- bis(11-methyldodecyl)(4-methyl-1,3-phenylene)dicarbamate
- Molecular formula:
- C35H62N2O4
- IUPAC Name:
- bis(11-methyldodecyl)(4-methyl-1,3-phenylene)dicarbamate
- Reference substance name:
- 11-methyldodecyl (3-(3-(3-(aminomethyl)benzyl)ureido)-4-methylphenyl)carbamate
- Molecular formula:
- C30H46N4O3
- IUPAC Name:
- 11-methyldodecyl (3-(3-(3-(aminomethyl)benzyl)ureido)-4-methylphenyl)carbamate
- Reference substance name:
- 1,1'-(4-methyl-1,3-phenylene)bis(3-(3-(aminomethyl)benzyl)urea)
- Molecular formula:
- C25H30N6O2
- IUPAC Name:
- 1,1'-(4-methyl-1,3-phenylene)bis(3-(3-(aminomethyl)benzyl)urea)
- Test material form:
- solid
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Results and discussion
- Details on results:
- This in vitro study was performed to assess the cytotoxic potential of ADDUKT Tl 65-MXDA 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, 31.3, 62.5, 125, 250,500, 1000 µg/ml. Complete medium (RPMI 1640 containing 10% (v/v) FCS) was used as negative control. The solvent control for the test item was RPMI 1640 medium containing 10% (v/v) FCS) and 1% DMSO. The solvent control for the positive control was also RPMI 1640 medium containing 10% (v/v) FCS and 10.0% (v/v) deion. water. SDS was used as positive control. The following concentrations were applied: 3.125, 6.25, 12.5, 25, 50, 100, 125, 250 µg/ml. The incubation time was 24 hours at 37 ± 1.5 oc. The negative control and the solvent control showed no reduction in cell viability. The positive control (SOS) induced a distinct dose-related reduction in cell viability. The calculated XTT5o value is 37.6 ~g/ml. No relevant cytotoxic effects were observed following incubation with ADDUKT Tl 65-MXDA up to the highest tested concentration (1000 µg/ml). Due to the Iack of cytotoxicity, a XTT50 value could not be calculated.
Applicant's summary and conclusion
- Conclusions:
- ln conclusion, it can be stated that in this study and under the experimental conditions reported, the test item ADDUKT Tl 65-MXDA does not possess any cytotoxic potential.
- Executive summary:
This in vitro study was performed to assess the cytotoxic potential of AOOUKT Tl 65-MXOA
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, 31.3, 62.5, 125, 250, 500, 1000 j.Jg/ml
Complete medium (RPMI 1640 containing 10% (v/v) FCS) was used as negative control.
The solvent control for the test item was RPMI 1640 medium containing 1 0% (v/v) FCS) and
1% OMSO.
The solvent control for the positive control was also RPMI 1640 medium containing 10%
(v/v) FCS and 10.0% (v/v) deion. water.
SOS was used as positive control. The following concentrations were applied:
3.125, 6.25, 12.5, 25, 50, 100, 125, 250 j.Jg/ml
The incubation time was 24 hours at 37 ± 1.5 oc.
The negative control and the solvent control showed no reduction in cell viability.
The positive control (SOS) induced a distinct dose-related reduction in cell viability.
No relevant cytotoxic effects were observed following incubation with AOOUKT Tl 65-MXOA
up to the highest tested concentration (1 000 j.Jg/ml). Oue to the Iack of cytotoxicity, a XTT 50
value could not be calculated.
ln conclusion, it can be stated that in this study and under the experimental conditions
reported, the test item AOOUKT Tl 65-MXOA does not possess any cytotoxic potential.
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