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EC number: 203-470-7 | CAS number: 107-18-6
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- Short-term toxicity to fish
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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:
- 2005
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study on primary toxic metabolite, acrolein.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar 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:
- Acrolein
- IUPAC Name:
- Acrolein
- Reference substance name:
- Acrylaldehyde
- EC Number:
- 203-453-4
- EC Name:
- Acrylaldehyde
- Cas Number:
- 107-02-8
- IUPAC Name:
- acrylaldehyde
- Details on test material:
- Source: Aldrich
Purity: > 90%
Constituent 1
Constituent 2
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor-1254 induced rat or hamster liver
- Test concentrations with justification for top dose:
- 0, 0.1, 0.3, 1.0 microgram/mL
- Vehicle / solvent:
- Distilled water
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Triethylenemelamine (0.15 ug/mL) or cyclophosphamide (15 ug/mL)
- Details on test system and experimental conditions:
- Cultures were handled under gold lights to prevent photolysis of bromodeoxyuridine-substitutedDNA. Each test consisted of concurrent vehicle and positive controls and of three doses of acrolein; the high dose was limited by toxicity. A single flask per dose was used.
In the test without S9, cells were incubated in McCoy's 5A medium with acrolein for 12 hours; Colcemid was added and incubation continued for 2 hours. The cells were then harvested by mitotic shake-off, fixed, and stained with Giemsa.
For the test with S9, cells were treated with acrolein and S9 for 2 hours, after which the treatment medium was removed and the cells incubated for 12 hours in fresh medium, with Colcemid present for the final 2 hours. Cells were harvested in the same manner as for the treatment without S9.
The harvest time for the test was based on the cell cycle information obtained in a SCE test. Cells were selected for scoring on the basis ofgood morphology and completeness ofkaryotype (21 ± 2 chromosomes). All slides were scored blind and those from a single test were read by the same person. One hundred first-division metaphase cells were scored at each dose level. Classes ofaberrations included simple (breaks and terminal deletions), complex (rearrangements and translocations), and other (pulverized cells, despiralized chromosomes, and cells containing 10 or more aberrations). Chromosomal aberration data are presented as percentage of cells with aberrations. - Evaluation criteria:
- To arrive at a statistical call for a trial, analyses were conducted on both the dose response curve and individual dose points. For a single trial, a statistically significant (P< 0.05) difference for one dose point and a significant trend (P < 0.015) were considered weak evidence for a positive response; significant differences for two or more doses indicated the trial was positive. A positive trend test in the absence of a statistically significant increase at any one dose resulted in an equivocal call. Ultimately, the trial calls were based on a consideration of the statistical analyses as well as the biological information available to the reviewers.
Results and discussion
Test results
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- ambiguous
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1. Chromosomal aberrations in CHO cells treated with acrolein.
Compound |
Concentration (ug/mL) |
Total Cells Scored |
Number of aberrations |
Aberrations/cell |
% cells with aberrations |
Without S9 |
|||||
Distilled water |
|
100 |
1 |
0.01 |
1 |
Acrolein |
0.1 0.3 1.0 |
100 100 100 |
2 2 5 |
0.02 0.02 0.05 |
2 2 5* |
Triethylenemelamine |
0.15 |
100 |
32 |
0.32 |
27 |
With S9 |
|||||
Distilled water |
|
100 |
0 |
0 |
0 |
Acrolein |
0.1 0.3 1.0 |
100 100 100 |
2 3 5 |
0.02 0.03 0.05 |
2 2 3 |
Cyclophosphamide |
15 |
100 |
47 |
0.47 |
33 |
* p < 0.042 for linear regression trend without S9.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
ambiguous without metabolic activation no significant difference between any treatment and controls
negative with metabolic activation
Chinese hamster ovary cells treated with up to 1.0 micrograms/mL for 14 hours did not show a clear effect on chromosomal aberrations either in presence or absence of S9. A weakly significant trend was seen in absence of S9, but no pairwise comparison of test concentrations against controls showed significant differences. The study director concluded that overall the study result was negative.
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