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

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Japanese guideline study conducted under GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals

Version / remarks:

Guideline of Reverse Mutation Assay in Bacteria

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

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:

471-480-0

Method

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Details on mammalian cell type (if applicable):

Ecoli WP2uvrA was also evaluated in the study (with and without activation)

Metabolic activation:

with and without

Metabolic activation system:

Phenobarbital and 5,6-benzoflavone-induced rat liver homogenate (S9-mix).

Test concentrations with justification for top dose:

0.05, 0.1, 0.5, 1, 5 ,10 ,and 50% in the atmosphere

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

no

True negative controls:

yes

Remarks:

sham exposed bacteria

Positive controls:

yes

Positive control substance:

other: AF-2, NaN3, 9AA as appropriate

Details on test system and experimental conditions:

- Exposure duration to test substance in gas exposure chamber followed by 24 - 48 hour exposure to test substance at 37°C

Evaluation criteria:

Study is considered valid if the mean colony counts of the control values of the strains are within acceptable ranges, if the results of the positive controls meet the criteria for a positive response, and if no more than 5 % of the plates are lost through contamination or other unforeseen events.
A test substance is considered to be positive in the bacterial gene mutation test if the mean number of revertant colonies on the test plates is concentration-related increased or if a two-fold or more increase is observed compared to that on the negative control plates.

A test substance is considered to be negative in the bacterial gene mutation test if it produces neither a dose-related increase in the mean number of revertant colonies nor a positive response at any of the test points.

Statistics:

None

Results and discussion

Test results

Test results 1

Species / strain:

E. coli WP2 uvr A pKM 101

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

Interpretation of results: negative with and without metabolic activation

HFO-1234ze was not mutagenic under the conditions employed in this study with or without metabolic activation.

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