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Toxicological information

Genetic toxicity: in vitro

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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)

Data source

Reference
Title:
No information
Author:
Anonymous
Year:
2007
Bibliographic source:
IUCLID4 data set, 2007

Materials and methods

Test guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
2-phenyl-2-imidazoline
EC Number:
213-313-4
EC Name:
2-phenyl-2-imidazoline
Cas Number:
936-49-2
Molecular formula:
C9H10N2
IUPAC Name:
2-phenyl-4,5-dihydro-1H-imidazole

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
Phenobarbital / beta-naphthoflavone co-induced rat liver S9 fraction
Test concentrations with justification for top dose:
50 to 5000 Ug/plate

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
GENOTOXIC EFFECTS:
- With metabolic activation: None
- Without metabolic activation: None
The positive controls were functional in the finally evaluated tests.
PRECIPITATION CONCENTRATION: Precipitation was not observed.
CYTOTOXIC CONCENTRATION (including effects on background lawn):
TA 98: 5000 Ug/plate (+ S9), 1500 Ug/plate (- S9)
TA 100: none (+ S9), 2000 Ug/plate (- S9)
TA 1535: 5000 Ug/plate (+ S9), >= 2000 Ug/plate (- S9)
TA 1537: 5000 Ug/plate (+ S9), 2000 Ug/plate (- S9)
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion