Registration Dossier

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

Constituent 1
Chemical structure
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-bromo-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluorooctane
Test material form:
liquid

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
S. typhimurium TA 1538
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.