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Toxicological information

Genetic toxicity: in vitro

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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:
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

Reference
Name:
Unnamed
Type:
Constituent

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.