Registration Dossier
Registration Dossier
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EC number: 238-178-9 | CAS number: 14283-07-9
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
- Report date:
- 2022
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 489 (In vivo Mammalian Alkaline Comet Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian erythrocyte micronucleus test
Test material
- Reference substance name:
- Lithium tetrafluoroborate, anhydrous
- EC Number:
- 238-178-9
- EC Name:
- Lithium tetrafluoroborate, anhydrous
- Cas Number:
- 14283-07-9
- Molecular formula:
- BF4.Li
- IUPAC Name:
- lithium tetrafluoroborate, anhydrous
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- Aqua ad iniectabilia
- Details on exposure:
- Based on the results of the solubility test, the test item was diluted in Aqua ad iniectabilia before treatment. All animals received a single volume orally of 10 mL/kg bw. The vehicle was chosen according to its relative non-toxicity for the animals.
Test Item formulations were transferred to BSL Munich together with the control formulations under consideration of stability. - Frequency of treatment:
- oral, daily on 3 consecutive days
Doses / concentrationsopen allclose all
- Dose / conc.:
- 50 mg/kg bw/day (nominal)
- Remarks:
- female
- Dose / conc.:
- 125 mg/kg bw/day (nominal)
- Remarks:
- female
- Dose / conc.:
- 250 mg/kg bw/day (nominal)
- Remarks:
- female
- Dose / conc.:
- 20 mg/kg bw/day (nominal)
- Remarks:
- male
- Dose / conc.:
- 50 mg/kg bw/day (nominal)
- Remarks:
- male
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Remarks:
- male
- Positive control(s):
- Ethyl methanesulfonate: 250 mg/kg bw
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- In conclusion, it can be stated that during the study described and under the experimental conditions reported, the test item Lithium Tetrafluoroborate did not induce biologically relevant DNA-strand breaks in liver, duodenum and glandular stomach after oral administration to rats.
Therefore, Lithium Tetrafluoroborate is considered to be non-DNA damaging under these experimental conditions in the in vivo mammalian Alkaline Comet Assay.
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