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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:
7.2. 2000 - 30.3.2000
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
2000

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: B.14 Mutagenicity, test of reversal mutagenicity, Salmonella typhimurium OECD NO. 471
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test batch: No.. 7/99

Method

Species / strain
Species / strain / cell type:
bacteria, other: Salmonella typhimurium : (TA1537, TA98, TA100 , TA1535)
Metabolic activation:
with and without
Metabolic activation system:
The simulation of the absorption metabolism was carried out by S9 fraction of the liver homogenate and the co-factors mixture.
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): .01 ... .5 µg/plate
Concentration range in the main test (without metabolic activation): .01 ... .5 µg/plate
Vehicle / solvent:
Solvent: dimethylsulphoxid

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
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
Observations:
According to the mentioned results Dusantox L is not

mutagenic, by test with metabolic as without metabolic
activation.
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):
negative with metabolic activation
negative without metabolic activation

The test results : whithout the bacterial backround changes - all concentration are not toxic.