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EC number: 614-637-2 | CAS number: 68603-75-8
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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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.17 (Mutagenicity - In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5300 - In vitro Mammalian Cell Gene Mutation Test
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- 2-Propanol, 1,1'-[[3-[(3-aminopropyl)amino]propyl]imino]bis-, N-tallow alkyl derivs.
- EC Number:
- 307-276-4
- EC Name:
- 2-Propanol, 1,1'-[[3-[(3-aminopropyl)amino]propyl]imino]bis-, N-tallow alkyl derivs.
- Cas Number:
- 97592-79-5
- IUPAC Name:
- 97592-79-5
- Reference substance name:
- 2-Propanol, 1,1'4[3-[(3aminopropyl)amino]propyljimino] bis-, N-tallow alkyl derivatives
- IUPAC Name:
- 2-Propanol, 1,1'4[3-[(3aminopropyl)amino]propyljimino] bis-, N-tallow alkyl derivatives
- Details on test material:
- - Name of test material (as cited in study report): POLYRAM SL
- Chemical Name: 2-Propanol, 1,1'-[[3-[(3aminopropyl)amino]propyl]imino] bis-, N-tallow alkyl derivatives
- Physical state: yellow viscous liquid
- Composition of test material, percentage of components: Fatty amine alkoxylated: 88.2%, Amines, tallow alkyl: 4.8 %, N-(tallow alkyl) triproplylenetetramine: 2.5%, Non amine: 2.5%, water content: 2.1%
- Purity test date: 12/01/2010
- Lot/batch No.: 96102715
- Expiration date of the lot/batch: 15/10/2011
- Storage condition of test material: at room temperature, protected from light
Constituent 1
Constituent 2
Method
- Target gene:
- Mammalian cell culture systems are used to detect mutations induced by chemical substances. This in vitro experiment is carried out to assess the potential of the test item to induce gene mutations by means of a Thymidine Kinase assay using the mouse lymphoma cell line L5178Y. The Thymidine Kinase (TK) system detects base pair mutations, frameshift mutations, small deletions as well as large, non-lethal deletions and rearrangements of the relevant chromosomes
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- - Type and identity of media:
see below under media in the section "Any other information on materials and methods incl. tables"
- Properly maintained: yes, see above
- Periodically checked for Mycoplasma contamination: yes/no
- Periodically checked for karyotype stability: yes/no
- Periodically "cleansed" against high spontaneous background: yes/no - Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 extract, male Wistar rats, induced with phenobarbital (80 mg/kg bw) and B-naphthoflavone (100 mg/kg bw) for three consecutive days by oral route.
- Test concentrations with justification for top dose:
- - short term pre-experiment (4 h exposure): 7, 15, 30 and 60 microg/mL with metabolic activation; 0.05, 0.2, 1.0, 4.0, 7.0 and 20.0 microg/mL
- experiment I (4 h duration) with metabolic activation: 3.0, 4.0, 6.0, 7.0, 7.75, 8.50, 9.25 and 10.0 microg/mL and without metabolic activation: 0.1, 0.2, 0.5, 1.0, 1.5, 2.0, 2.5 and 3.0 microg/mL
- experiment II (24 h duration) with metabolic activation: 2.0, 4.0, 5.5, 6.5, 7.25, 8.00, 8.75 and 9.50 microg/mL and without metabolic activation: 0.20, 0.35, 0.50, 0.65, 0.80, 0.90, 1.00 and 1.10 microg/mL - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: none
- Justification for choice of solvent/vehicle: test item is dispersible in water
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: Benzo[a]pyrene (B[a]P), Ethylmethanesulfonate (EMS), Methylmethanesulfonate (MMS),
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Preincubation period:
- Exposure duration: 4 h and 24 h (with and without activation)
- Expression time (cells in growth medium):
- Selection time (if incubation with a selection agent):
- Fixation time (start of exposure up to fixation or harvest of cells):
SELECTION AGENT (mutation assays):
see below in the section "Any other information on materials and methods incl. tables"
NUMBER OF REPLICATIONS:
not applicable
NUMBER OF CELLS EVALUATED:
number of cells seeded: 300'000, number of cells evaluated see result tables
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other:
Cytotoxicity is determined by measuring the colony-forming ability and the growth rate of cultures. The treated cultures are maintained 48-72 h to allow near optimal phenotypic expression of induced mutations. - Evaluation criteria:
- There are several criteria for determining a positive result:
- clear and dose-related increase in the mutant frequency,
- biologically relevant response (at least a 2-fold increase of mutant frequencies related to the respective negative control values and higher than the historical range of negative controls) for at least one of the dose groups,
- combined with a positive effect in the mutant frequency, an increased occurrence of small colonies (slow growth colonies) indicated by a low large/small colonies ratio (1.5 times the ratio of clastogenic controls MMS and/or B[a]P) is an indication for potential clastogenic effects and/or chromosomal aberrations. - Statistics:
- According to the OECD guidelines, the biological relevance is the criterion for the interpretation of results. A statistical evaluation of the results is not regarded as necessary.
Results and discussion
Test results
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: none reported
- Effects of osmolality: none reported
- Evaporation from medium: unlikely given the low vapour pressure of the substance
- Water solubility: test item reported to be dispersible in water
- Precipitation: Precipitation of the test item was noted only in the pre-experiments at 30 and 60 µg/mL with and at 7 and 20 µg/mL without metabolic activation
- Other confounding effects: none reported
RANGE-FINDING/SCREENING STUDIES:
yes, see results below
COMPARISON WITH HISTORICAL CONTROL DATA: yes, but historical control data not reported in detail
ADDITIONAL INFORMATION ON CYTOTOXICITY: - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
- Table 1: Pre-Experiment for Toxicity, with metabolic activation
Test Group |
Concen-tration [µg/mL] |
Number of Cells seeded |
Number of Cells 4 h after Treatment |
Number of Cells 24 h after |
Number of Cells 48 h after |
Relative Suspension Growth (RSG) [%] |
NC1 |
0 |
300000 |
323000 |
925000 |
1410000 |
100.00 |
NC2 |
300000 |
360000 |
980000 |
1450000 |
||
1 |
7 |
300000 |
201000 |
322000 |
1280000 |
51.88 |
2 |
15 |
300000 |
11200 |
0 |
0 |
n.d. |
3 (P) |
30 |
300000 |
26700 |
0 |
0 |
n.d. |
4 (P) |
60 |
300000 |
26300 |
0 |
0 |
n.d. |
NC: Negative control
(P): Precipitation
RSG: [(value TSG / value TSG of corresponding controls) x 100]
n.d.: no data
- Table 2: Pre-Experiment for Toxicity, without metabolic activation
Test Group |
Concen-tration [µg/mL] |
Number of Cells seeded |
Number of Cells 4 h after Treatment |
Number of Cells 24 h after |
Number of Cells 48 h after |
Relative Suspension Growth (RSG) [%] |
NC1 |
0 |
300000 |
281000 |
803000 |
1610000 |
100.00 |
NC2 |
300000 |
287000 |
845000 |
1620000 |
||
1 |
0.05 |
300000 |
251000 |
742000 |
1570000 |
99.06 |
2 |
0.20 |
300000 |
313000 |
902000 |
1550000 |
95.34 |
3 |
1.00 |
300000 |
288000 |
676000 |
1570000 |
78.65 |
4 |
4.00 |
300000 |
57100 |
47600 |
179000 |
20.07 |
5 (P) |
7.00 |
300000 |
9710 |
8300 |
5800 |
3.82 |
6 (P) |
20.00 |
300000 |
121000 |
48800 |
31000 |
1.64 |
NC: Negative control
(P): Precipitation
RSG: [(value TSG / value TSG of corresponding controls) x 100]
- for the other tabulated resuts please see the attached pdf-document
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
In conclusion, in the described mutagenicity test under the experimental conditions reported, the test item 2-Propanol, 1,1'-[[3-[(3-aminopropyl)amino]propyl]imino]bis-, N-tallow alkyl derivs. is considered to be non-mutagenic in the mouse lymphoma thymidine kinase locus using the cell line L5178Y. - Executive summary:
In the present study (Bioservice Scientific Laboratories 2010) 2-Propanol, 1,1'-[[3-[(3-aminopropyl)amino]propyl]imino]bis-, N-tallow alkyl derivs. was assessed for its potential to induce mutations at the mouse lymphoma thymidine kinase locus using the cell line L5178Y.
The selection of the concentrations was based on data from the pre-experiments. In experiment I 10.0 .tg/mL (with metabolic activation) and 3.0 µg/mL (without metabolic activation) were selected as the highest concentrations. In experiment II 9.5 µg/mL (with metabolic activation) and 1.1 .tg/mL (without metabolic activation) were selected as the highest concentrations.
Experiment I and II with metabolic activation and experiment I without metabolic activation were performed as 4 h short-term exposure assay. Experiment II without metabolic activation was performed as a 24 h long-term exposure assay.
The test item was investigated at the following concentrations:
Experiment I
with metabolic activation:
3.0, 4.0, 6.0, 7.0, 7.75, 8.50, 9.25 and 10.0 gg/mL
and without metabolic activation:
0.1, 0.2, 0.5, 1.0, 1.5, 2.0, 2.5 and 3.0 p.g/mL
Experiment II
with metabolic activation:
2.0, 4.0, 5.5, 6.5, 7.25, 8.00, 8.75 and 9.50 .tg/mL
and without metabolic activation:
0.20, 0.35, 0.50, 0.65, 0.80, 0.90, 1.00 and 1.10 vg/mL
Precipitation of the test item was noted only in the pre-experiments.
Growth inhibition was observed in experiment I and II with and without metabolic activation.
In experiment I with metabolic activation the relative total growth (RTG) was 16.52% for the highest concentration (10.0 µg/mL) evaluated. The highest concentration evaluated without metabolic activation was 3.0 µg/mL with a RTG of 11.10%. In experiment II with metabolic activation the relative total growth (RTG) was 17.47% for the highest concentration (9.5 lig/mL) evaluated. The highest concentration evaluated without metabolic activation was 1.1 pg/mL with a RTG of 15.57%.
In experiment I and II no biologically relevant increase of mutants was found after treatment with the test item (with and without metabolic activation). No dose-response relationship was observed.
Additionally, in experiment I and II colony sizing showed no clastogenic effects induced by the test item under the experimental conditions (with and without metabolic activation). EMS, MMS and B[a]P were used as positive controls and showed distinct and
biologically relevant effects in mutation frequency. Additionally, MMS and B[a]P significantly increased the number of small colonies, thus proving the efficiency of the test system to indicate potential clastogenic effects.
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