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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
12.08.1987-22.08.1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study meets the requirements of the OECD Principles of Good Laboratory Practice, Paris, 1992.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

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
Metabolic activation:
with and without
Test concentrations with justification for top dose:
Dose range finding test: 5000, 500, 50, 5 µgI/plate.Mutation tests: 5000, 1500, 500, 150, 50 µgI/plate.
Controlsopen allclose all
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Remarks:
water
Positive controls:
yes
Positive control substance:
2-nitrofluorene
Remarks:
Migrated to IUCLID6: without S-9 mix
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Remarks:
water
Positive controls:
yes
Positive control substance:
other: 2-Aminoanthracene
Remarks:
with S-9 mix

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):negativeIt is concluded that no evidence of mutagenic potential of iodixanol was obtained in this bacterial test system at the dose levels used.
Executive summary:

Iodixanol was not toxic towards the tester strains. Therefore 5000 µgI/plate was chosen as the top dose level in the mutation tests.

No substantial increases in revertant colony numbers of any of the five tester strains were observed following treatment with iodixanol at any dose level, either in the presence or absence of metabolic activation (S-9 mix).

In the Ames test, five different strains of Salmonella typhimurium (TA 1535, 1537, 1538, 98 and 100) were tested for revertant colonies both in the presence and in the absence of a metabolising system (S9 mix) (10). Iodixanol was not toxic towards the tester strains, and therefore 5000 μgI/plate was chosen as the top concentration in the mutation tests. There were no substantial increases in revertant colonies in any of the tester strains following treatment with iodixanol at any concentration, either in the presence or in the absence of the S9 mix. The positive control substances in the test system (N-ethyl-N'-nitrosoguanidine, 9-aminoacridine, 2-nitrofluorene and 2-aminoanthracene) were highly mutagenic, thus confirming the sensitivity of the test system.

It was concluded that no evidence of mutagenic potential of iodixanol was obtained in this bacterial test system at the concentrations used.