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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)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
With this test it is not possible to identify certain oxidising mutagens, cross-linking agents and hydrazines. Such substances may be detected by E.coli WP2 strains or S. typhimurium TA102 which have an AT base pair at the primary reversion site in stead of GC base pairs which the strains tested in this study have. No independent repeat was performed to confirm the negative result.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
The procedures used in this mutagenic assay are described in detail by Ames et al (1975).
GLP compliance:
no
Remarks:
pre-GLP
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Liladox
di-cetyl peroxydicarbonate

Method

Target gene:
Histidine operon
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
S. typhimurium TA 1538
Metabolic activation:
with and without
Metabolic activation system:
S9-mix
Test concentrations with justification for top dose:
0, 0.012, 0.04, 0.11, 0.33, 1.0 mg test product per 0.1 ml acetone per plate
0, 12, 40, 110, 330, 1000 µg/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: Acetone
- Justification for choice of solvent/vehicle: None
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Remarks:
Acetone
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: See below.
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: 72 hours

SELECTION AGENT (mutation assays): histidine

NUMBER OF REPLICATIONS: triplicate

NUMBER OF CELLS EVALUATED: colonies (revertants which are histidine-independent) are counted, and the background lawn of bacterial growth examined.

DETERMINATION OF CYTOTOXICITY
- Method: relative total growth
Evaluation criteria:
No data

Results and discussion

Test resultsopen allclose all
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:
cytotoxicity
Remarks:
With strain TA 1538 the backgound lawn of bacterial growth, was slightly less dense at 1mg per plate than in the concomitant control plates.
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

It was concluded that the test substance did not reveal mutagenic activity in the Salmonella/microsome mutagenicity test.
Executive summary:

The mutagnic activity. Of the test subsatnce was examined in the Salmonella/micosome mutagenicity test, using a set of five histidine

requiring mutants of S. typhimurium (TA 1535, TA 1537, TA1538, TA 98 and TA 100) and liver homogenate of Aroclor-induced rats.

Incorporation of the test product with the bacteria up to non-inhibitory levels (i.e. 1.0 mg per plate) did not increase the numbers of his revertants in any of the five tester strains either in the presence or in the absence of the liver microsome activation system.

It was concluded that the present results did not reveal any mutagenic activity of the test sample in the Salmonella/microsome mutagenicity test.