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Genetic toxicity: in vitro

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in vitro DNA damage and/or repair study
Type of genotoxicity: DNA damage and/or repair
Type of information:
experimental study
Adequacy of study:
supporting study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The reference does not totally comply with the specific testing guideline: no positive controls or metabolic activation system were included. Due to the missing positive and negative control, the study was considered not reliable.

Data source

Reference Type:
Rec assay and mutagenicity studies on metal compounds
Kanematsu N., Hara M. and Kada T.
Bibliographic source:
Mutation Research, 77:109-116

Materials and methods

Test guideline
other: no guideline specified
Principles of method if other than guideline:
In this study where the genotoxicity of metal compounds were evaluated, antimony trioxide was tested in the Bacillus subtilis Rec assay .
GLP compliance:
not specified
Type of assay:
Bacillus subtilis recombination assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Diantimony trioxide
EC Number:
EC Name:
Diantimony trioxide
Cas Number:
Molecular formula:
oxostibanyl stibinate
Test material form:
not specified


Species / strain
Species / strain / cell type:
bacteria, other: Bacillus subtilis H17 (Rec+, arg- try-) and M45 (Rec-, arg- try-)
Test concentrations with justification for top dose:
The antimony trioxide was dissolved in distilled water at a concentration of 0.001-10 M.
2.5 µmol (729 µg)/disk
Untreated negative controls:
Positive controls:
Details on test system and experimental conditions:
In this study the genotoxicity of 127 metal compounds were evaluated. One of the compounds was antimony trioxide that was tested in the Bacillus
subtilis Rec assay.
The strains were grown overnight in B-2 broth (meat extract 10g, polypeptone powder 10g, and NaCl 5 g in 1L, pH adjusted to 7.0) and conserved at -80°C with 12.5% glycerol supplemention. On the day of the experiment, each stock was melted and streaked radially from small pipettes onto
B-2 agar.
A 0.05 ml portion of the metal solution was dropped onto a filter paper disk (diameter 10 mm) and the disk was placed on the starting point of the
streak. The plates were kept at 4°C for 24 hours and then incubated at 37°C overnight.
When the DNA damage is produced by a chemical and subjected to cellular recombination-repair function, the growth of recombination-deficient
cells is usually inhibited much more than that of wild cells.
Evaluation criteria:
When a metal compound has the capacity to damage DNA, growth of the Rec- strain of Bacillus subtilis must be more inhibited than that of the wild
strain. To predict the DNA-damaging capacity, the inhibition zones were measured and compared.
A difference in the inhibition length of more than 4 mm was judged as positive.

Results and discussion

Additional information on results:
The treatment with antimony trioxide resulted in a difference in inhibition length of 5 mm and was thereby classified as positive.

Any other information on results incl. tables

Table 1: Results of the Rec assay on positive metal compounds

metal compound

concentration of solution (M)

inhibition length (mm)



H17 (Rec+)

M45 (Rec-)







a + Less than 6 mm and more than 4 mm of difference.

Applicant's summary and conclusion

Interpretation of results (migrated information):

The treatment with antimony trioxide resulted in a difference in inhibition length of 5 mm and was thereby classified as positive.