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Registration Dossier
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EC number: 945-205-4 | CAS number: -
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1999-05-05 to 1999-06-21
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Automatically generated during migration to IUCLID 6, no data available
- IUPAC Name:
- Automatically generated during migration to IUCLID 6, no data available
- Details on test material:
- - Name of test material (as cited in study report): Zeostop X (silver alumino-silikate)
- Chemical name: Zeolite, cuboidal, crystalline, synthetic, non-fibrous
- Framework: cuboidal
- Related CAS number: 1318-02-1
- Analytical purity: approx. 100%
- Lot/batch No.: MR 453 136
- Physical state: white powder
- Composition of test material, percentage of components (surface modified with Ag): Si/Al molarity 1.24
Al2O3: 25.6%
CaO 0.08%
Fe2O3 0.00%
K2O 00.08%
MgO 00.00%
Na2O 11.71%
SiO2 37.33%
Ag2O 02.80%
loss resulting from combustion (900°C)
- Expiry date: May 2000
- Storage: in dark and at room temperature
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Metabolic activation system:
- liver post-mitochondrial fraction from rats, induced with Aroclor 1254 (S-9)
- Test concentrations with justification for top dose:
- between 27.5 and 72.5 µg/mL without S-9, and between 164 and 400 µg/mL with S-9
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-Nitroquinoline-1-oxide and cyclophosphamide
- Details on test system and experimental conditions:
- Culture medium: McCoy´s 5A medium
In Experiment 1, treatment in the absence and presence of S-9 was for 3 hours followed by a 17 hour recovery period prior to harvest (3+l7). The S-9 used was prepared from a rat liver post-mitochondrial fraction (S-9) from Aroclor 1254-induced animals. The test article dose levels for chromosome analysis were selected by evaluating the effect of Zeostop X on cell numbers. Chromosome aberrations were analysed at three consecutive dose levels. The highest concentrations chosen for evaluation, 67.11 and 400 µg/mL, induced approximately 48% and 63% reduction in cell number in the absence and presence of S-9 respectively.
In Experiment 2, treatment in the absence of S-9 was continuous for 20 hours. Treatment in the presence of S-9 (using S-9 prepared from animals induced with phenobarbitone and beta-naphthoflavone) was for 3 hours only followed by a 17 hour recovery period prior to harvest (3+17). Chromosome aberrations were analysed at three consecutive dose levels. The highest concentrations chosen for analysis were, 72.54 and 313.2 µg/mL, which induced approximately 54% and 49% reduction in cell number in the absence and presence of S-9, respectively.
Appropriate negative control cultures were included in the test system in both experiments under each treatment condition. 4-Nitroquinoline-1-oxide and cyclophosphamide were employed as positive control chemicals in the absence and presence of S-9, respectively. - Evaluation criteria:
- Cells were harvested, fixed and transferred to microscope slides. After the slides had dried the cells were stained with Giemsa. Chromosome analysis was performed microscopically.
Results and discussion
Test results
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- without S-9: at 67.1 µg/ml (exp 1) and 72.5 µg/ml (exp 2) ; with S-9: at 400 µg/l (exp 1) and 313.2 µg/l (exp 2)
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- The test article was poorly soluble and undissolved material was observed at all concentrations.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
The
proportion of cells with structural aberrations in the negative control
cultures fell within historical solvent control ranges. Cells receiving
4-Nitroquinoline-1-oxide and cyclophosphamide both induced statistically
significant increases in the proportion of cells with structural
aberrations.
Treatment of cells with Zeostop X in the absence and presence of S-9
resulted in increased frequencies of cells with aberrations. Frequencies
which exceeded historical negative control ranges in both replicates and
where the total number of aberrant cells was significantly higher than
the concurrent negative control were observed at either the high or
intermediate concentration analysed from all treatment regimes. The
total number of aberrations seen was clearly elevated in most treated
cultures and exchanges, which are observed only infrequently in negative
controls, were induced.
Experiment 1 (3+17) without S-9 mix (200 cells were scored each):
µg/mL cells...with
aberrations with
aberrations
including
gaps excluding
gaps
-----------------------------------------------------------
solvent 0
0
27.49 4
3
42.95 7
6
67.11 26
17
pos. 30
27
Reduction in cell number with increasing concentration 0% (solvent),
27.49%, 20%, 48%; value for positive control not given
Experiment 1 (3+17) with S-9 mix:
µg/mL cells...with
aberrations with
aberrations
including
gaps excluding
gaps
-----------------------------------------------------------
solvent 1
1
163.8 5
2
320 3
2
400 27
20
pos. 102
101
Reduction in cell number with increasing concentration 0% (solvent), 8%,
29%, 63%; value for positive control not given
Experiment 2 (20+0) without S-9 mix:
µg/mL cells...with
aberrations with
aberrations
including
gaps excluding
gaps
-----------------------------------------------------------
solvent 6
4
37.87 5
1
61.66 33
23
72.54 14
10
pos. 51
40
Reduction in cell number with increasing concentration 0% (solvent),
26%, 59%, 54%; value for positive control not given
Experiment 2 (3+17) with S-9 mix:
µg/mL cells...with
aberrations with
aberrations
including
gaps excluding
gaps
-----------------------------------------------------------
solvent 7
4
226.3 10
6
266.2 18
15
313.2 22
14
pos. 187
186
Reduction in cell number with increasing concentration 0% (solvent),
19%, 42%, 49%; value for positive control not given
Increased frequencies of cells with numerical aberrations which exceeded
historical negative control ranges were observed under all treatment
conditions. The effect was attributable to endoreduplication. It should
be noted that the biological significance of endoreduplication and its
likely occurrence in vivo is not clear.
Numerical aberrations observed:
Experiment 1 (3+17) without S-9 mix
µg/mL cells
counted
H
E
P
-----------------------------------------------------------
solvent 206
1
0
5
27.49 204
0
0
4
42.95 213
1
5
7
67.11 260
1
52
7
pos. 210
3
0
7
Experiment 1 (3+17) with S-9 mix:
µg/mL cells
counted
H
E
P
-----------------------------------------------------------
solvent 205
0
1
4
163.8 210
2
0
8
320 243
0
35
8
400 264
0
58
6
pos. 202
0
0
2
Experiment 2 (20+0) without S-9 mix:
µg/mL cells
counted
H
E
P
-----------------------------------------------------------
solvent 211
2
0
9
37.87 210
1
5
4
61.66 274
0
65
9
72.54 263
0
59
4
pos. 207
3
0
4
Experiment 2 (3+17) with S-9 mix:
µg/mL cells
counted
H
E
P
-----------------------------------------------------------
solvent 208
2
0
6
226.3 212
0
10
2
266.2 229
1
25
3
313.2 284
0
81
3
pos. 203
0
0
3
endoreduplication (E)
polyploid (P)
hyperdiploid (H)
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive
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