Registration Dossier

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: We had no access to the study. Data provided by our customer for our ELINCS notification (without Letter of Access)

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2003

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
Version / remarks:
Directive 92/69/CEE, Méthode B.13/14 Directive OCDE No. 471 US EPA 40 CFR Partie 799, Vol. 62, No.158
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
Additional strain / cell type characteristics:
not specified
Species / strain / cell type:
E. coli, other: CM891
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
Homogénat de foie dérivé de rats induits par l'Aroclor 1254.
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 5 ... 5000 µg/plate
Concentration range in the main test (without metabolic activation): 5 ... 5000 µg/plate
Vehicle / solvent:
Solvent: Diméthylsulfoxyde

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with
Genotoxicity:
not specified
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
( 1500 µg/plate)
Species / strain:
E. coli, other: CM891
Metabolic activation:
with
Genotoxicity:
not specified
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
( 1500 µg/plate)
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
without
Genotoxicity:
not specified
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
( 1500 µg/plate)
Species / strain:
E. coli, other: CM891
Metabolic activation:
without
Genotoxicity:
not specified
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
( 1500 µg/plate)
Additional information on results:
Observations:
Le premier test était un dosage d'incorporation sur plaque standard, et le second impliquait un stade de pré- incubation.

Une toxicité a été observée envers les souches testées durant le premier test de mutation avec 5000 µg/plaque et avec 5000 et 1500 µg/plaque dans le second test de mutation.
Remarks on result:
other: other: main test
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