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EC number: 829-608-1 | CAS number: 106396-29-6
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 2014-05-28 to 2014-07-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2,4,8,10-tetra(tert-butyl)-6-hydoroxy-12H-dibenzo[d,g] [1,3,2]dioxaphosphocin, 6-oxide
- EC Number:
- 829-608-1
- Cas Number:
- 106396-29-6
- Molecular formula:
- C29 H43 O4 P
- IUPAC Name:
- 2,4,8,10-tetra(tert-butyl)-6-hydoroxy-12H-dibenzo[d,g] [1,3,2]dioxaphosphocin, 6-oxide
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Purity: > 99%
Batch No.: 10181
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 Mix
- Test concentrations with justification for top dose:
- To set the dose levels for the main tests, the 100 mg/mL solution was diluted to 4 times at a common ratio of 4 and a total of 5 dose levels selected (19.5, 78.1, 313, 1250 and 5000 μg/plate) in the dose-finding test.
In the dose-finding test, precipitation of the test article on the plate was observed at 5000 μg/plate with or without metabolic activation. Coloration on the plate was not observed at any dose levels irrespective of the presence/absence of metabolic activation. Growth inhibition was observed at 78.1 μg/plate or more in S. typhimurium TA1537 without metabolic activation, and at 313 μg/plate or more in S. typhimurium TA 98, TA 100 and TA 1535 without metabolic activation, and at 1250 μg/plate or more E. coli WP2 uvrA without metabolic activation and other strains with metabolic activation.
There was neither increase in the number of revertant colonies of two-fold or more in comparison with that of the negative control group nor dose-response for any strains with or without metabolic activation. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMF
- Justification for choice of solvent/vehicle: Based on the information of the sponsor, since the test article was insoluble in water, DMSO and acetone, the solubility test was conducted with DMF and 1,4-dioxane. As the result, DMF was used as the vehicle in this study because it was soluble at 100 mg/mL, and 1,4-dioxane was insoluble at 100 mg/mL.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- DMF
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- positive control for TA 100, TA 98, TA 1537 with metabolic activation
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- positive control for TA 1535 without metabolic activation
- Positive controls:
- yes
- Positive control substance:
- other: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide (AF-2)
- Remarks:
- positive control for TA 100, TA 98, WP2 uvrA with metabolic activation
- Positive controls:
- yes
- Positive control substance:
- other: 2-Methoxy-6-chloro-9-[3-(2-chloroethyl)- aminopropylamino]acridine.2HCl (ICR-191)
- Remarks:
- positive control for TA 1537 without metabolic activation
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene (2AA)
- Remarks:
- positive control for TA 1535, WP2 uvrA with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 20 minutes
Number of Plates: 2 plates at each dose level in the dose-finding test, 3 in the two main tests. - Evaluation criteria:
- If a two-fold or more increase in the number of revertant colonies compared to that of spontaneous revertant colonies (the negative control value), dose-response and reproducibility were noted, or even if no clear dose-response was observed but there were at least two-fold increase in the number of revertant colonies in comparison with that of spontaneous revertant colonies and reproducibility in the two main tests, the test article was judged to be positive.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Positive controls validity:
- valid
- Additional information on results:
- Dose-finding test:
- Observetion: Precipitation of the test article on the plate was observed at 5000 μg/plate with or without metabolic activation. Coloration on the plate was not observed at any dose levels irrespective of the presence/absence of metabolic activation. Growth inhibition was observed at 78.1 μg/plate or more in S. typhimurium TA1537 without metabolic activation, and at 313 μg/plate or more in S. typhimurium TA98, TA100 and TA1535 without metabolic activation, and at 1250 μg/plate or more E. coli WP2 uvrA without metabolic activation and other strains with metabolic activation.
There was neither increase in the number of revertant colonies of two-fold or more in comparison with that of the negative control group nor dose-response for any strains with or without metabolic activation.
First main test and second main test:
- Observetion: In both the two main tests, neither precipitation nor coloration of the test article on the plate was observed at any dose levels irrespective of the presence/absence of metabolic activation. Growth inhibition was observed at 39.1μg/plate or more in S. typhimurium TA1537 without metabolic activation, and at 156 μg/plate or more in S. typhimurium TA1535 without metabolic activation, and at 313 μg/plate or more in S. typhimurium TA98 and TA100 without metabolic activation, and at 1250 μg/plate or more E. coli WP2 uvrA without metabolic activation and other strains with metabolic activation.
There was neither increase in the number of revertant colonies of two-fold or more in comparison with that of the negative control group nor dose-response for any strains irrespective of the presence/absence of metabolic activation. - Remarks on result:
- other: Growth inhibition was observed at 156 μg/plate or more
Applicant's summary and conclusion
- Conclusions:
- The test item was judged to have no gene mutation inducibility (negative) under the conditions of this study.
- Executive summary:
In order to examine the gene mutation inducibility of the test item, a reverse mutation assay was conducted in Salmonella typhimurium (hereinafter referred to as S. typhimurium) TA 100, TA 1535, TA 98 and TA 1537, and Escherichia coli (hereinafter referred to as E. coli) WP2 uvrA with or without metabolic activation by the pre-incubation method according to OECD Guideline 471.
N,N-dimethylformamide (hereinafter referred to as DMF) was used as the vehicle for the test article. A dose-finding test was conducted with dose levels between 19.5 and 5000 μg/plate to set the dose levels for the main test. From the result of the dose-finding test, the minimum dose which showed growth inhibition was selected as the maximum dose for the main test, and the main tests were conducted at 6 dose levels between 2.44 and 78.1 μg/plate in the S. typimurium TA 1537 without metabolic activation, and between 9.77 and 313 μg/plate in the S. typimurium TA 98, TA 100 and TA 1535 without metabolic activation, and between 39.1 and 1250 μg/plate in the E. coli WP2 uvrA without metabolic activation and other strains with metabolic activation. The main test was conducted twice at the same dose levels.
Precipitation on the plate was observed at 5000 μg/plate with or without metabolic activation. Coloration by the test article was not observed at any dose levels irrespective of the presence/absence of metabolic activation.
In the observation of bacterial background lawn using a stereoscopic microscope, growth inhibition was observed at 39.1 μg/plate or more in S. typhimurium TA 1537 without metabolic activation, and at 156 μg/plate or more in S. typhimurium TA 1535 without metabolic activation, and at 313 μg/plate or more in S. typhimurium TA 98 and TA 100 without metabolic activation, and at 1250 μg/plate or more E. coli WP2 uvrA without metabolic activation and other strains with metabolic activation.
In the two main tests, there was neither increase in the number of revertant colonies of two-fold or more in comparison with that of the negative control group nor dose-response in any strains irrespective of the presence/absence of metabolic activation.
In conclusion, the test item was judged to have no gene mutation inducibility (negative) under the conditions of this study.
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