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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: well documented GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Principles of method if other than guideline:
according to Ames, B.N. et al.: Mutat. Res. 31, 347-364, 1975
GLP compliance:
yes (incl. certificate)
Remarks:
testing lab.
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name of the test substance used in the study report: C-800, SN-2592

Method

Target gene:
several S. typhimurium strains
Species / strain
Species / strain / cell type:
other: Salmonella typhimurium strains TA 98, 100, 1535, 1537, 1538
Metabolic activation:
with and without
Metabolic activation system:
rat liver activation system
Test concentrations with justification for top dose:
1.0, 10, 100, 500, 1000, 2500, 5000, 10000 ug/plate
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
yes
Positive controls:
yes
Positive control substance:
other: without metabolic activation: sodium azide, 2-Nitrofluorene, 9-aminoacridine; with metabolic activation: 2-aminoanthracene
Details on test system and experimental conditions:
Doses for the mutagenicity assay were selected from a preliminary range-finding study was performed with tested strain TA 100 at 14 dose levels (i.e from 1.22 to 10000 ug/plate). In this study the test material was toxic to the indicator strain at and above 2500 ug/plate as evidenced by the reduced number of revertants on the minimal media plates. In the mutagenicity assay eight dose leves from 1 to 10000 ug/plate were tested with and without metabolic activation, using one plate per dose level in the agar incorporation method. As vehicel DMSO was chosen. S-9 mix was prepared from livers of Aroclor induced male Sprague-Dawley rats.
Plates were incubated at 37° C for approx. 48 hours.

Results and discussion

Test results
Species / strain:
other: S. typhimurium strains TA 98, 100, 1535, 1537, 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
other: >= 2500 ug/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
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):
negative

The test substance did not exhibit genetic activity in any of the assays conducted in the present study and was not mutagenic under these test conditions.