Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1996

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
2-mercaptobenzothiazolyl-(Z)-(2-aminothiazol-4-yl)-2-(tert-butoxycarbonyl) isopropoxyiminoacetate
EC Number:
419-040-9
EC Name:
2-mercaptobenzothiazolyl-(Z)-(2-aminothiazol-4-yl)-2-(tert-butoxycarbonyl) isopropoxyiminoacetate
Cas Number:
89604-92-2
Molecular formula:
C20H22N4O4S3
IUPAC Name:
tert-butyl 2-{[(Z)-[1-(2-amino-1,3-thiazol-4-yl)-2-(1,3-benzothiazol-2-ylsulfanyl)-2-oxoethylidene]amino]oxy}-2-methylpropanoate

Method

Species / strain
Species / strain / cell type:
bacteria, other: sat TA 98, 100, 1535, 1537, 1538
Metabolic activation system:
S9-Mix aus Rattenleber "ENGLISH" S9-mix from rat liver
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 50 ... 5000 μg/plate
Concentration range in the main test (without metabolic activation): 50 ... 5000 μg/plate
Vehicle / solvent:
Solvent: DMSO

Results and discussion

Test resultsopen allclose all
Species / strain:
other: as specified above
Metabolic activation:
with
Genotoxicity:
other: n.a.
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
5000 μg/plate
Species / strain:
other: as specified above
Metabolic activation:
without
Genotoxicity:
other: n.a.
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
5000 μg/plate
Additional information on results:
Observations:
Keine Abweichungen gegenüber den Kontrollgruppen
"ENGLISH"
No changes

Applicant's summary and conclusion

Conclusions:
negative with metabolic activation
negative without metabolic activation