Carbon tetrafluoride

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

S. typhimurium tester strain TA97a using ICR 191 as positive control was used as a substitute for strains TA97 and/or TA1537.

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Octafluorocyclobutane

EC Number:

204-075-2

EC Name:

Octafluorocyclobutane

Cas Number:

115-25-3

Molecular formula:

C4F8

IUPAC Name:

octafluorocyclobutane

Method

Target gene:

hisD6610 (for S.typhimurium TA97a)
hisD3052 (for S.typhimurium TA98)
hisG46 (for S.typhimurium TA100)
hisG46 (for S.typhimurium TA1535)
trpE (for E.coli WP2)

Species / strain

Species / strain / cell type:

other: Salmonella typhimurium TA97a, TA98, TA100, TA1535 and Escherichia coli WP2

Details on mammalian cell type (if applicable):

S.typhimurium TA97a, TA98, TA100: deletion of uvrB; rfa; pKM101
S.typhimurium TA1535: deletion of uvrB; rfa
E.coli WP2: deletion of uvrA; pKM101

Metabolic activation:

with and without

Metabolic activation system:

Aroclor-induced rat liver S9

Test concentrations with justification for top dose:

Target concentrations: 0, 20, 40, 60, 80 and 100%

Trial 1:
- Without metabolic activation: 0, 25.6, 38.4, 57.2, 74.5, 89.0 %
- With metabolic activation: 0, 26.0, 40.6, 57.9, 68.4, 90.5 %

Trial 2:
- Without metabolic activation: 0, 26.7, 41.0, 54.5, 68.6, 90.0 %
- With metabolic activation: 0, 14.5, 42.0, 28.9, 67.5, 85.2 %

Controls

Untreated negative controls:

yes

Positive controls:

yes

Positive control substance:

9,10-dimethylbenzanthracene

2-nitrofluorene

sodium azide

N-ethyl-N-nitro-N-nitrosoguanidine

other: ICR 191 Acridine mutagen (ICR 191) and 2-aminoanthracene

Results and discussion

Test results

Key result

Species / strain:

other: Salmonella typhimurium TA97a, TA98, TA100, TA1535 and Escherichia coli WP2

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Untreated negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

Under the conditions of this study, no evidence of mutagenic activity was detected in either trial with the test substance.
Based on the findings, H-24619 (octafluorocyclobutane) is concluded to be negative for the induction of mutagenicity in the bacterial reverse mutation test in Salmonella typhimurium and Escherichia coli in the presence and absence of the Aroclor-induced rat liver S9.