Registration Dossier
Registration Dossier
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EC number: 209-162-9 | CAS number: 557-21-1
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:
- 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosomal Aberration Test)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Zinc cyanide
- EC Number:
- 209-162-9
- EC Name:
- Zinc cyanide
- Cas Number:
- 557-21-1
- Molecular formula:
- Zn(CN)2
- IUPAC Name:
- ZINC DICYANIDE
- Test material form:
- solid: particulate/powder
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster lung (CHL/IU)
- Metabolic activation:
- with and without
- Metabolic activation system:
- After pre-incubation, each plate was divided into three groups: short time treatments with or without metabolic activation and the continuous treatment without metabolic activation.
- Test concentrations with justification for top dose:
- The high dose of the test substance was 2,000 µg/mL, which was the limit dose recommended in the guideline. The high dose was sequentially diluted to produce lower dose levels (1,000, 500, 250, 125, 62.5, 31.3, 15.6, 7.81 µg/mL). The negative control group was set.
- Vehicle / solvent:
- Normal saline batch No KAH5112 1B, KAH5056 2B
Controls
- Untreated negative controls:
- yes
- Remarks:
- Normal saline. The vehicle of the test substance, normal saline, was used as the negative control.
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- mitomycin C
- Details on test system and experimental conditions:
- In the short time treatments with and without metabolc activation, cells were treated with the test substance for 6 hours.In the continuous treatment without metabolic activation, cells were treated with the test substance for 24 hours.
- Evaluation criteria:
- Evaluation of the validity of the study resutl was conducted based on the following criteria. (1) The frequency of cells with chromosome aberrations in the negative and positive control groups in below 5% and above 10%, respectively. (2) The dose levels which have more than 300 metaphases per dose are above three. (3) the cultures do not show any evidence of contamination.
- Statistics:
- statistical analysis on the frequency of cells with chromosome abberations was performed using SAS prgram (Version 9.3, SAS Institute Inc., U.S.A.). For the data of cell aberration, Fisher's exact test was used for comparison of the negative control group to the test substance groups and the positive control group (p < 0.05).
Results and discussion
Test results
- Species / strain:
- Chinese hamster lung (CHL/IU)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- The frequency of cells with chromosomal aberrations was less than 5% in the short time treatment with and without metabolic activation and the continuous treatment without metabolic activation and statistical analysis on the frequency of cells with chromosome aberrations change was not found. The positive control group, the frequency of cells with structural chromosomal aberrations was at more than 10% increased compared to that in the negative control group.
Applicant's summary and conclusion
- Conclusions:
- In conclusion, the test substance, the frequency of cells with chromosome aberrations was below 5%, zinc cyanide, did not show a potential to induce chromosomal aberrations in Chinese Hamster Lung (CHL/IU) cell under the conditions of this study.
- Executive summary:
For that endpoint, one reliable study to assess the chromosomal aberration on the registered substance on Chinese Hamster Lung (CHL/IU) was available. The study was performed according to the OECD Guideline 473 (In Vitro Mammalian Chromosomal Aberration).
Under the experimental conditions, the registered substance " Zinc cyanide batch n°10185145" has a frequency of cells with chromosome aberrations below 5%. Therefore, Zinc cyanide did not show a potential to induce chromosomal aberrations.
The validity criteria were successful and the study was therefore regarded as acceptable for that endpoint.
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