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EC number: 205-351-5 | CAS number: 139-07-1
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Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From March 22, 2001 to September 25, 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Quaternary ammonium compounds, benzyl C12-C16 (even numbered) -alkyldimethyl chlorides
- Molecular formula:
- C12-14H25-29-(CH3)2-C6H5-N.CL
- IUPAC Name:
- Quaternary ammonium compounds, benzyl C12-C16 (even numbered) -alkyldimethyl chlorides
Constituent 1
- Specific details on test material used for the study:
- - Physical state: Extremely pale yellow, slightly viscous liquid with white precipitate
- Analytical purity: The purity of the a.s. is typically >93% ADBAC as described in Section 2; the a.s. is supplied in aqueous/alcohol solution of 50% or 80% a.s. Doses are based on a.s. (i.e. corrected for the dilution in alcohol/water)
- Lot/batch No.: DEGE001033
- Expiration date of the lot/batch: January 2002
- Stability under test conditions: The test substance is hydrolytically and photolytically stable under the conditions of this study and has been shown to be stable in aqueous, alcohol and alcohol/aqueous solutions for extended periods, e.g. at least five years under standard laboratory conditions.
- Storage condition of test material: Room temperature in darkness
Method
Species / strain
- Species / strain / cell type:
- lymphocytes: human
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbitone and ß-naphthoflavone - induced rat liver S9 fraction
- Test concentrations with justification for top dose:
- Preliminary toxicity test: 0, 19.5, 39, 78.1, 156.25, 312.5, 625, 1250, 2500 and 5000 µg/mL (with and without activation)
Chromosome aberration test:
Experiment 1: 0, 4, 8, 16, 20 µg/mL (with and without activation)
Experiment 2: 0, 4, 8, 12, 16, 24 µg/mL (with and without activation) - Vehicle / solvent:
- Eagle’s minimal essential medium with HEPES buffer (MEM)
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- Negative (media) control
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Eagle’s minimal essential medium with HEPES buffer (MEM)
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- (Without S9, at 0.4 and 0.25 µg/mL in Experiment 1 and 2 respectively)
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- (With S9, at 12.5 and 10.0 µg/mL in experiment 1 and 2 respectively)
- Details on test system and experimental conditions:
- Method of application: In Eagle’s minimal essential medium with HEPES buffer (MEM)
Duration:
- Exposure duration:
Without metabolic activation: 4 and 24h
With metabolic activation: 4h
- Exposure procedure: The cultures were incubated at 37˚C for 4 or 24h (as appropriate) in the presence of the test substance at predetermined concentrations/vehicle/positive controls with or without the S9 reaction mixture.
- Expression time: Approximately 20h after initiation of treatment
- Fixation time: 4h
Spindle inhibitor: Demecolcine (colcemid, 0.1 μg/mL) was added approx. 2 h prior to harvest timeSpindle
Stain: When the slides were dry they were stained in 5% Gurrs Giemsa solution for 5 minutes, rinsed, dried and coverslipped using mounting medium.
Number of replications: At least 2 slides/ flask
Number of cell evaluated: 100 consecutive well-spread metaphase cells (if possible), from each culture were counted, and if the cell had 44-48 chromosomes, any gaps, breaks or rearrangements were noted.
Determination of the cytotoxicity: A total of 2000 lymphocyte cell nuclei were counted and the number of cells in metaphase recorded and expressed as the mitotic index and as a percentage of the vehicle control value. - Statistics:
- The frequency of cells with aberrations (both including and excluding gaps) and the frequency of polyploid cells were compared, where necessary, with the concurrent vehicle control value using Fisher’s Exact test and chi-squared test.
Results and discussion
Test results
- Key result
- Species / strain:
- lymphocytes: human
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- slightly toxic at 20 µg/mL in experiment 1 (with S9 activation) and toxic at 16 µg/mL in experiment 1 and at 20 µg/mL in experiment 2 (without S9 activation))
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 1. Results of chromosomal aberration in human lymphocytes (Experiment 1)
Treatment (μg/mL) |
S9 Activation |
Treatment Time |
Mean Mitotic Index |
Cells Scored |
Total Number of Aberrations |
Cells with Numerical Aberrations + Gaps(%) |
Cells with Structural Aberrations - Gaps(%) |
Vehicle |
- |
4 |
4.2 |
200 |
11 7 |
5.0 |
3.5 |
Test substance |
|||||||
4 |
- |
4 |
3.2 |
200 |
6 1 |
3.0 |
0.5 |
8 |
- |
4 |
2.7 |
200 |
2 1 |
1.0 |
0.5 |
16 |
- |
4 |
1.5 |
200 |
7 5 |
3.0 |
2.0 |
Positive control (MMC) 0.4 |
- |
4 |
2.2 |
200 |
83 64 |
32.0 |
26.0** |
|
|||||||
Vehicle |
+ |
4 |
3.9 |
200 |
5 1 |
2.5 |
0.5 |
Test substance |
|||||||
8 |
+ |
4 |
2.3 |
200 |
4 1 |
2.0 |
0.5 |
16 |
+ |
4 |
2.1 |
200 |
7 4 |
2.5 |
1.0 |
20 |
+ |
4 |
1.6 |
200 |
7 3 |
3.5 |
1.5 |
Positive control (CP) 12.5 |
+ |
4 |
1.4 |
300 |
76 45 |
20.0 |
12.0** |
Treatment: Cells from the 4-h treatment regimens were harvested 20h after the initiation of the treatments.
Frequency of Aberrant Cells: **, p ≤ 0.001
Table 2. Results of chromosomal aberration in human lymphocytes (Experiment 2)
Treatment (μg/mL) |
S9 Activation |
Treatment Time |
Mean Mitotic Index |
Cells Scored |
Total Number of Aberrations |
Cells with Numerical Aberrations + Gaps(%) |
Cells with Structural Aberrations - Gaps(%) |
Vehicle |
- |
4 |
7.0 |
200 |
4 1 |
2.0 |
0.5 |
Test substance |
|||||||
4 |
- |
24 |
4.9 |
200 |
6 4 |
2.0 |
1.0 |
8 |
- |
24 |
2.7 |
200 |
6 6 |
2.5 |
2.5 |
12 |
- |
24 |
2.6 |
200 |
12 2 |
6.0 |
1.0 |
Positive control (MMC) 0.2 |
- |
24 |
2.3 |
200 |
115 86 |
37.0 |
30.0** |
|
|||||||
Vehicle |
+ |
4 |
5.9 |
200 |
8 4 |
2.5 |
0.5 |
Test substance |
|||||||
8 |
+ |
4 |
5.2 |
200 |
7 3 |
3.5 |
1.5 |
16 |
+ |
4 |
3.3 |
200 |
0 0 |
0 |
0 |
24 |
+ |
4 |
3.4 |
200 |
1 1 |
0.5 |
0.5 |
Positive control (CP) 12.5 |
+ |
4 |
1.4 |
200 |
108 79 |
33.5 |
27.0** |
Treatment: Cells from both the 4-h and 24 h treatment regimens were harvested 20 h after the initiation of the treatments.
Frequency of Aberrant Cells: **, p ≤ 0.001
For further details, refer to the attachment under 'Attached background material'
Applicant's summary and conclusion
- Conclusions:
- Based on the results of the study, the test substance is not considered to be non-clastogenic to human lymphocytes with and without metabolic activation.
- Executive summary:
A study was conducted to determine the in vitro genetic toxicity of the test substance, C12-16 ADBAC (50 -80% active) in chromosome aberration test, according to OECD Guideline 473 and EU Method B.10, in compliance with GLP. This experiment was performed in human lymphocyte cells. Duplicate cell cultures of human lymphocytes, treated with the test substance, were evaluated for chromosome aberrations at three dose levels, together with vehicle and positive controls (mitomycin-C (without S9) and cyclophosphamide (with S9)). Four treatment conditions were used for the study. Experiment 1 and 4 h exposure with and without metabolic activation was followed by a 20 h expression period. In Experiment 2, the 4 h exposure with metabolic activation was repeated while in the absence of metabolic activation the exposure time was increased to 24 h. The doses studied were 0, 4, 8, 16, 20 µg/mL (with and without activation) in Experiment 1 and 0, 4, 8, 12, 16, 24 µg/mL (with and without activation) in Experiment 2. The test substance was considered negative for chromosomal aberrations in human lymphocytes in vitro under the S9 metabolic activation and non-activation conditions of the assay. There was no indication of chromosomal ploidy changes in cultures exposed to the test substance in either the presence or absence of S9 mix. Mutant frequencies of all cultures treated with the test substance were within the acceptable range for background mutant frequencies. Based on the results of the study, the test substance is not considered to be non-clastogenic to human lymphocytes with and without metabolic activation (Durward, 2001).
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