Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
in vitro gene mutation study in mammalian cells
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD guideline under GLP compliance

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
GLP compliance:
yes (incl. QA statement)
Type of assay:
mammalian cell gene mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Imidazole
EC Number:
206-019-2
EC Name:
Imidazole
Cas Number:
288-32-4
Molecular formula:
C3 H4 N2
IUPAC Name:
1H-imidazole
Test material form:
other: Solid, colorless to yellowish

Method

Species / strain
Species / strain / cell type:
mouse lymphoma L5178Y cells
Metabolic activation:
with and without
Metabolic activation system:
S9
Test concentrations with justification for top dose:
700 μg/mL (approx. 10 mM) Imidazole was used as top concentration both with and without S9 mix at 4 hour exposure time and without S9 mix at 24 hour exposure time
Controls
Untreated negative controls:
yes
Positive controls:
yes
Positive control substance:
cyclophosphamide
methylmethanesulfonate

Results and discussion

Test results
Species / strain:
mouse lymphoma L5178Y cells
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity

Applicant's summary and conclusion