1-Propene, 1,3,3,3-tetrafluoro-

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)

GLP compliance:

yes (incl. QA statement)

Type of assay:

in vitro mammalian chromosome aberration test

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

471-480-0

EC Name:

-

Cas Number:

1645-83-6

Molecular formula:

Hill formula: C3H2F4 CAS formula: C3H2F4

IUPAC Name:

(1E)-1,3,3,3-tetrafluoroprop-1-ene

Method

Species / strain

Species / strain / cell type:

lymphocytes: human

Cytokinesis block (if used):

Colcemid

Metabolic activation:

with and without

Metabolic activation system:

S9-mix

Test concentrations with justification for top dose:

0, 10, 20, 40, 60, and 76 % in the atmosphere

Controls

Untreated negative controls:

yes

Remarks:

sham exposed

Negative solvent / vehicle controls:

no

True negative controls:

no

Positive controls:

yes

Positive control substance:

cyclophosphamide

mitomycin C

Details on test system and experimental conditions:

METHOD OF APPLICATION: substance is a liquified gas. Lymphocytes were exposed in a modular incubator chamber in atmospheric concnetrations of 19% O2, 5% CO2, and up to 76% test substance


DURATION
- Preincubation period: 48hrs
- Exposure duration: 4hrs
- Expression time (cells in growth medium):20 or 44 hrs
- Fixation time (start of exposure up to fixation or harvest of cells): 26-50 hrs


SPINDLE INHIBITOR (cytogenetic assays): colcemid
STAIN (for cytogenetic assays): Geimsa


NUMBER OF REPLICATIONS:2


NUMBER OF CELLS EVALUATED:100


DETERMINATION OF CYTOTOXICITY
- Method: mitotic index

Evaluation criteria:

Biological relevance and statistical significance are both considered in the evaluation of the results.

Statistics:

Fischer's exact probability test (two sided)

Results and discussion

Test results

Species / strain:

lymphocytes: human

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

slight cytotoxicity at highest concentration with metabolic activation

Vehicle controls validity:

not applicable

Untreated negative controls validity:

valid

True negative controls validity:

not applicable

Positive controls validity:

valid

Additional information on results:

Test substance did not induce a statistically significant increase in the number of aberrant cells at any concentration or time point analysed with compared to the number of aberrant cells observed in the negative (control air) control cultures.

The positive controls mitomycin C (without S9) and cyclophosphamide (with S9) induced the expected statistically significant increase in the incidence of structural chromosomes.

Applicant's summary and conclusion

Conclusions:

Under the conditions of this study, the test substance was not clastogenic in cultured human lymphocytes.