Registration Dossier
Registration Dossier
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EC number: 215-128-4 | CAS number: 1304-29-6
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Barium chloride
- EC Number:
- 233-788-1
- EC Name:
- Barium chloride
- Cas Number:
- 10361-37-2
- Molecular formula:
- BaCl2
- IUPAC Name:
- Barium Chloride
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): barium chloride dihydrate
- EC number: 233-788-1
- Substance type: pure active substance
- Physical state: a white crystalline granule or powder
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Details on mammalian cell type (if applicable):
- no details available
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium, duplicate cultures
DURATION (test without S9)
- Exposure duration: In the test without S9, cells were incubated with barium chloride dihydrate for 10 hours.
Spindel inhibitor: (cytogenetic assays): Colcemid was added and incubation continued for 2 hours.
Stain: (for cytogenetic assays): The cells were then harvested by mitotic shake-off, fixer, and stained with Giemsa.
DURATION (test with S9)
- Exposure duration: In the test with S9, cells were treated with barium chloride dihydrate and S9 for 2 hours, after which the treatment medium was removed and the cells were incubated for 10 to 11 hours in fresh medium.
Spindel inhibitor: (cytogenetic assays): Colcemid was added for the final 2 hours.
Stain: (for cytogenetic assays): The cells were then harvested by mitotic shake-off, fixer, and stained with Giemsa.
NUMBER OF CELLS EVALUATED: One hundred first-division metaphase cells were scored at each dose level. Classes of aberrations included simple (breaks and terminal deletions), complex (rearrangements and translocations), and other (pulverised cells, despiralised chromosomes, and cells containing 10 or more aberrations). - Evaluation criteria:
- no data
- Statistics:
CA data are presented as percentage of cells with aberrations. 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) are considered weak evidence for a positive response; significant differences for two or more doses indicate the trial is positive. A positive trend test in the absence of a statistically significant increase at any one dose results in an equivocal call (Galloway et al., 1987).
Results and discussion
Test results
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- no data
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
The in vitro chromosome aberration test in CHO cells was negative with and without metabolic activation.
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