1-bromoheptadecafluorooctane

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

3 January 1990 - 22 March 1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

Principles of method if other than guideline:

90% emulsion

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

1-bromoheptadecafluorooctane

EC Number:

207-028-4

EC Name:

1-bromoheptadecafluorooctane

Cas Number:

423-55-2

Molecular formula:

C8BrF17

IUPAC Name:

1-bromoheptadecafluorooctane

Test material form:

liquid

Method

Species / strain

Species / strain 1

Species / strain / cell type:

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

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 1538

Species / strain 3

Species / strain / cell type:

E. coli WP2 uvr A

Additional strain / cell type characteristics:

DNA polymerase A deficient

Metabolic activation:

with and without

Metabolic activation system:

Liver S9, exogenous metabolic activation system of mammalian microsomal enzymes derived from Aroclor-induced rat (male Sprague-Dawley rats) liver.

Test concentrations with justification for top dose:

10 to 10000µg/plateDoses selected after a dose rangefinding study. Routinely, the maximum dose selected to be tested in the mutagenicity assay should demonstrate cytotoxicity (if possible).

Vehicle / solvent:

5% dextroseSolvent: PFOB

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

4-nitroquinoline-N-oxide

2-nitrofluorene

sodium azide

N-ethyl-N-nitro-N-nitrosoguanidine

other:

Details on test system and experimental conditions:

Salmonella: In addition to a mutation in the histidine operon, the tester strains contain two additional mutations which enhance their sensitivity to some mutagenic compounds. The “rfa wall mutation” and a deletion of the uvrB gene.Strains TA98 and TA100 also contain the R-factor plasmid, pKM101, which further increases the sensitivity of these strains to some mutagens. E.coli: the tester strain used was the tryptophan auxotroph WP2uvrA- as described by Green and Muriel (1976). In addition to a mutation in the tryptophan operon, the tester strain contains a uvrA DNA repair deficiency.

Results and discussion

Test results

Species / strain:

other: As listed above

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

The results of the Salmonella - Escherichia Coli/Mammalian-Microsome Reverse Mutation Assay indicate that under the conditions of this study, the substance did not cause a positive increase in the number of revertants per plate of any of the tester strains either in the presence or absence of microsomal enzymes prepared from Aroclor-induced rat liver.No cytotoxicity was observed in either the presence or absence of S9 with either tester strain as evidenced by no observed decrease in the number of revertants per plate and the observation of a normal background. In addition, although the stock dilutions were emulsions, no macroscopic particulate was observed on the plates.