3,3,3-trifluoropropene

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

3 (not reliable)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Principles of method if other than guideline:

The test substance was tested in Salmonella typhimurium in atmospheres that contained up to 49% of the compound, with and without metabolic activation.

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

3,3,3-trifluoropropene

EC Number:

211-637-0

EC Name:

3,3,3-trifluoropropene

Cas Number:

677-21-4

Molecular formula:

C3H3F3

IUPAC Name:

3,3,3-trifluoroprop-1-ene

Details on test material:

- Purity: 100% (nominal; no analysis reported)

Method

Target gene:

histidine

Species / strain

Species / strain / cell type:

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

Metabolic activation:

with and without

Metabolic activation system:

Aroclor-induced rat liver S9

Test concentrations with justification for top dose:

Trial 1: 0, 9, 17, 31, 46%
Trial 2: 0, 9, 16, 31, 47%
Trial 3: 0, 10, 18, 33, 49%

Controls

Untreated negative controls:

yes

Positive controls:

yes

Positive control substance:

other: Chloroethylene (VC)

Results and discussion

Test results

Species / strain:

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

Metabolic activation:

with and without

Genotoxicity:

positive

Remarks:

Authors note that this result was possibly due to the presence of a contaminant in the test sample cylinder.

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Remarks:

Not toxic at concentrations ≤46%

Vehicle controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

During Trial 2 and Trial 3, it became necessary to replace an empty gas sample cylinder for a full one. There was a corresponding decrease in the observed mutagenic activity with the first dose level metered from the full cylinder. Mutagenic activity then increased with increasing concentration. These inflection points occurred at the 16% concentration in Trial 2 and the 33% concentration in Trial 3 (the change-over to a full cylinder in Trial 2 occurred between metering chamber #1 and chamber #2, such that plates in chamber #1 were treated with the nearly empty cylinder and chamber #2 plates were treated with gas from the full cylinder). The observed effect is consistent with the possible presence of a mutagenic contaminant in these samples of the test material. As the gas sample cylinder was emptied by metering during testing, the concentration of any contaminant less volatile than the major component would increase in the effluent. This is especially true if the cylinder required some heating to maintain the appropriate pressure at the flow-meter for accurate dispensing. A comparison between an “empty” and a “full” cylinder of test material was made by gas chromatograph. Two unidentified peaks similar to those observed in isomers of a previously tested material found to be mutagenic at low concentrations were observed in the sample from the “empty” cylinder, and only a trace of one component was observed in the “full” cylinder.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
positive Authors note that this result was possibly due to the presence of a contaminant in the test sample cylinder.

The test substance was concluded to be positive in this assay. However, the authors note that this result was possibly due to the presence of a contaminant in the test sample cylinder.

Executive summary:

The test substance was tested in Salmonella typhimurium strains TA1535, TA1537, TA98, and TA100 in atmospheres that contained up to 49% of the compound. The test substance was mutagenic in the microbial assay either the presence and absence of a liver microsomal system. However, the authors note that this result was possibly due to the presence of a contaminant in the test sample cylinder.