Registration Dossier

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
other: experimental study on a mixture containing sodium levulinate as minor component
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Remarks:
TA 97, TA 104 and TA 1538
Metabolic activation:
with and without
Metabolic activation system:
Rat liver S9
Test concentrations with justification for top dose:
0.1, 0.5, 1, 10, 20, 50, 100 µg/ 20 µL/ plate
The highest dose was selected on the basis of the preliminary cytotoxicyty test
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
yes
Positive controls:
yes
Positive control substance:
sodium azide
mitomycin C
other: 2-aminoanthracene (1 µg/ 20 µl/ plate), nitrofluorene (2 µg/ 20 µl/ plate), 1,8-dihydroxyanthraquinone (50 µg/ 20 µl/ plate)
Details on test system and experimental conditions:
A preliminary test to assess the cytotoxicity of the test item was performed.
Each concentration and control were tested in triplicate in the main test.

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 97
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium 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
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 102
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium, other: 104
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Untreated negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
non mutagenic
Executive summary:

The test substance was tested for mutagenic effects in vitro in histidine-requiring strains of Salmonella typhimurium, according to an internal method similar to the OECD Guideline 471. The test was performing without and with metabolic activation in the range of concentration of 0.1 to 100 µg/20µl/plate, using strains of Salmonella typhimurium (TA 97, TA 98, TA 100, TA 102, TA 104, TA 1535, TA 1537 and TA 1538). Each concentration and control were tested in triplicate.

No substantial increase in revertant colony numbers of any of the tester strains was observed following treatment with the test substance at any concentration level, neither in the presence nor absence of metabolic activation.

Based on the results of these experiments, it is concluded that the test substance did not induce gene mutations in the strains of S. typhimurium used, both with and without metabolic activation.