Registration Dossier
Registration Dossier
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EC number: 211-477-1 | CAS number: 647-42-7
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian cell study: DNA damage and/or repair
- Remarks:
- Type of genotoxicity: DNA damage and/or repair
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 486 (Unscheduled DNA Synthesis (UDS) Test with Mammalian Liver Cells in vivo)
- Deviations:
- no
- Remarks:
- (The study was conducted according to the guideline in effect at the time of study conduct.)
- GLP compliance:
- yes
- Type of assay:
- unscheduled DNA synthesis
Test material
- Reference substance name:
- 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctan-1-ol
- EC Number:
- 211-477-1
- EC Name:
- 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctan-1-ol
- Cas Number:
- 647-42-7
- Molecular formula:
- C8H5F13O
- IUPAC Name:
- 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctan-1-ol
- Details on test material:
- - Purity: 98.5%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:(WI) WU BR
- Sex:
- male
Administration / exposure
- Route of administration:
- oral: gavage
- Duration of treatment / exposure:
- 2 - 4 hours; 12 - 16 hours
- Frequency of treatment:
- once, by oral gavage
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
750 mg.kg-bw
Basis:
other: nominal dose by gavage
- Remarks:
- Doses / Concentrations:
1500 mg.kg-bw
Basis:
other: nominal dose by gavage
- No. of animals per sex per dose:
- 6
- Control animals:
- yes, concurrent vehicle
Examinations
- Tissues and cell types examined:
- Hepatocytes, net nuclear grain (NNG) count in liver cells
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- yes
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
It is concluded that the test substance did not induce unscheduled DNA synthesis in liver cells of male rats - Executive summary:
The test substance was examined for its potential to induce unscheduled DNA synthesis (UDS), a measure of DNA repair activity, in primary liver cells after short term exposure of rats. Two doses (1500 and 750 mg/kg-bw) were administered to male rats by gavage. Rats treated with the vehicle (com oil) were used as negative controls. At two time points (2-4 hours and 12-16 hours after treatment), animals were sacrificed by perfusion for isolation of hepatocytes. Unscheduled DNA synthesis was examined by autoradiography in monolayer cultures of hepatocytes, incubated in the presence of [methyl- ³H]-thymidine. The test substance did not increase the mean net nuclear grain (NNG) count in liver cells, compared to that in the control rats. This demonstrates that the test substance did not induce unscheduled DNA synthesis.
It is concluded that the test substance did not induce unscheduled DNA synthesis in liver cells of male rats, exposed to the test substance by gavage under the conditions used in this study.
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