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EC number: 247-611-0 | CAS number: 26322-14-5
Genetic toxicity: in vitro
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:
- 1 981
- 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 substance name:
- Dihexadecyl peroxodicarbonate
- EC Number:
- 247-611-0
- EC Name:
- Dihexadecyl peroxodicarbonate
- Cas Number:
- 26322-14-5
- Molecular formula:
- C34H66O6
- IUPAC Name:
- 1-[({[(hexadecyloxy)carbonyl]peroxy}carbonyl)oxy]hexadecane
- Details on test material:
- Liladox
di-cetyl peroxydicarbonate
Constituent 1
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.
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