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:
other information
Study period:
05 to 07 May 2010
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Unsuitable test system and documentation is insufficient for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
no guideline available
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strainopen allclose all
Species / strain:
S. typhimurium TA 98
Additional strain characteristics:
other: hisD3052 rfa uvrB +R
Metabolic activation:
with and without
Metabolic activation system:
S9-mix
Species / strain:
other: Salmonella his- TA7001 - 7006
Metabolic activation:
with and without
Metabolic activation system:
S9-mix
Test concentrations with justification for top dose:
0, 16, 50, 160, 500, 1600 and 5000 µg/mL
Controls
Negative controls:
yes
Remarks:
ethanol
Solvent controls:
not specified
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
4-nitroquinoline-N-oxide
2-nitrofluorene
other: 2-Aminoanthracene
Remarks:
-S9-Mix: 625/1200 ng/ml 4-nitroquinoline N-oxide/2-nitrofluorene +S9-Mix: 10 µg/ml 2-aminoanthracene

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
no
Negative controls valid:
yes
Positive controls valid:
yes
Species / strain:
other: Salmonella his- TA7001 - 7006
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
no
Negative controls valid:
yes
Positive controls valid:
yes

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

Under the experimental conditions of the study, the substance is considered to be not mutagenic with and without metabolic activation in a bacterial reverse mutation test conducted on the Salmonella typhimurium TA98 and mixed strains (TA7001 - 7006), testing up to 5000 µg/mL.