Registration Dossier
Registration Dossier
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EC number: 206-575-6 | CAS number: 355-04-4
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Justification for type of information:
- Saturated perfluorocarbons have very similar toxicological properties and so a "read across" approach is justified.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Perfluoroperhydrophenanthrene
- EC Number:
- 400-470-0
- EC Name:
- Perfluoroperhydrophenanthrene
- Cas Number:
- 306-91-2
- Molecular formula:
- C14F24
- IUPAC Name:
- 1,1,2,2,3,3,4,4,4a,4b,5,5,6,6,7,7,8,8,8a,9,9,10,10,10a-Tetracosafluorophenanthrene
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- Swiss
- Details on species / strain selection:
- Specific Pathogen Free CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Kept i disposable plastic cages, maintained at 22degC, 30 changes of air per hour; free access to Spratt's Laboratory Diet Number 1 and tap water.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- 1% methyl cellulose
- Details on exposure:
- 2026 mg/ml of test material was used, to give a total dose of 40520 mg/kg
- Duration of treatment / exposure:
- Single dose
- Frequency of treatment:
- Single dose
- Post exposure period:
- 72 hours
Doses / concentrations
- Dose / conc.:
- 40 520 mg/kg bw (total dose)
- No. of animals per sex per dose:
- 15
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Mitomycin C (by intraperitoneal injection).
Examinations
- Tissues and cell types examined:
- Bone marrow smears taken at 24, 48 and 72 hours examined for micronuclei
- Evaluation criteria:
- Ratio of polychromatic to normochromatic erythrocytes.
- Statistics:
- At least 1000 erythrocytes from each animal.
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Octafluoropropane is not genetically toxic
- Executive summary:
Octafluoropropane is not genetically toxic
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