Registration Dossier

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:
Octafluoropropane is a gas, making testing difficult. However, 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:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
mouse
Strain:
Swiss
Details on species / strain selection:
Specific Pathogen Free CD-1
Sex:
male/female
Details on test animals 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