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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Target gene:
his
Species / strain
Species / strain / cell type:
other: S. typhimurium TA 1535, TA 97a, TA 98, TA 100, and TA 102
Metabolic activation:
with and without
Metabolic activation system:
Phenobarbital and beta-naphtoflavone induced rat liver S9 mix
Test concentrations with justification for top dose:
Two independent studies were conducted.
Test material concentrations were 0.016, 0.05, 0.16, 0.5, and 1.6 mg/plate in strains TA97a, TA100, and TA1535 with and without S9 and TA98 and TA102 without S9 in the first study. Test material concentrations were 0.05, 0.16, 0.5, 1.6 and 5.0 mg/plate in strains TA98 and TA102 with S9 in the second study.
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
Controlsopen allclose all
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene (TA98, TA100, TA97a, and TA1535), and danthron (TA102)
Remarks:
with metabolic activation
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: ICR 191 (TA97a), 4-nitro-o-phenylendiamine (TA98), nitrofurantoine (TA100), sodium azide (TA1535), and cumene hydroperoxide (TA102)
Remarks:
without metabolic activation
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Expression time (cells in growth medium): 48 hours

NUMBER OF REPLICATIONS: triplicates tested


DETERMINATION OF CYTOTOXICITY
- Method: background lawn
Evaluation criteria:
Mutagenic if there is a concentration effect relationship and the induction rate is >= 2.
Statistics:
Arithmetic mean values and standard deviations were calculated from colonies per plate of three replicates.

Results and discussion

Test results
Species / strain:
other: S. typhimurium TA 1535, TA 97a, TA 98, TA 100, and TA 102
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
The test material was cytotoxic at 1.6 mg/plate with and without S9 in strains TA97a, TA100 and TA1535. The test material was cytotoxic at 1.6 mg/plate without S9 and at 5.0 mg/plate with S9 in strains TA98 and TA102.
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion