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EC number: 907-672-2 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
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- Additional physico-chemical properties of nanomaterials
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- Endpoint summary
- Stability
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
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- Toxicological Summary
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- Acute Toxicity
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- Genetic toxicity
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- Additional toxicological data

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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study carriet out according to to internationally accepted guidelines. No deviations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 9th addendum
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese guidelines: Kanpoan No.287, Eisei No.127, Heisei 09/10/31 Kikyoku No.2
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- DBPP (multi-constituent)
- IUPAC Name:
- DBPP (multi-constituent)
- Test material form:
- other: Liquid
- Details on test material:
- - Name of test material (as cited in study report): DBPP reaction mass
- Analytical purity:99.8%
- Composition of test material, percentage of components:
* 70,4% dibutyl phenyl phosphate
* 19,1% butyl diphenyl phosphate
* 10,3% tributyl phosphate
- Lot/batch No.: 1149785
- Expiration date of the lot/batch: july 2012
- Stability in solvent: unknown
- Storage condition of test material: +2 to +8°C
Constituent 1
Method
- Target gene:
- Salmonella typhimurium histidine (his)
Escherichia coli tryptophan (trp)
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:
- Mammalian Microsomal Fraction S9 Mix
- Test concentrations with justification for top dose:
- In the pre-experiment (reported as experiment I), the concentration range of the test item was 3-5000 ug/plate.
Since toxic effects were observed, 8 concentrations were tested in experiment II and 5000 ug/plate was chosen as maximal concentration:
3 - 10 - 33 - 100 - 333 - 1000 - 2500 and 5000 ug/plate - Vehicle / solvent:
- DMSO - the solvent was chosen because of its solubility properties and it relative non-toxicity to the bacteria.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Remarks:
- with and without metabolic activation
- Positive control substance:
- other: multiple positive controls - see "details on test system and conditions"
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
- Experiment I: plate incorporation
- Experiment II: pre-incubation
POSITIVE CONTROL SUBSTANCES:
- Without metabolic activation:
* sodium azide -- TA 1535, TA 100
* 4-nitro-o-phenylene-diamine -- TA 1537, TA 98
* methyl methane sulfonate -- WP2 uvrA
-With metabolic activation:
* 2-aminoanthracene -- all strains
DETERMINATION OF TOXICITY:
To evaluate the toxicity of the test item a pre-experiment was performed with strains TA 1535, TA 1537, TA 98, TA 100 and WP2 uvrA.
Eight concentrations were tested for toxicity and mutation induction with three plates each. The experimental conditions in this pre-experiment were the same as described for experiment I (plate incorporation test).
Toxicity of the test item results in a reduction in the number of spontaneous revertants or a clearing of the bacterial background lawn.
NUMBER OF REPLICATIONS: for each strain and dose level including the controls, 3 plates were used.
PRECULTURES:
From the thawed ampoules of the strains 0,5 mL suspension was transferred into 250 mL Erlenmeyer flasks containing 20 mL nutrient medium. A solution of 20 uL ampicillin (25 ug/mL) was added to the strains TA 98 and TA 100. This nutrient medium contains per litre: 8g nutrient broth (MERCK, 64293 Darmstadt/Germany) and 5 g NaCl (MERCK, 64293 Darmstadt/Germany).
The bacterial cultures were incubated in a shaking water bath for 4 hours at 37°C The optical density of the bacteria was determined by absorption measurement and the obtained values indicated that the bacteria were harvested at the late exponential or early stationary phase (10E08 - 10E09 cells/mL).
PLATE INCORPORATION TEST (EXPERIMENT I):
The following materials were mixed in a test tube and poured onto the selective agar plates:
* 100 uL test solution at each dose level (solvent or reference mutagen solution)
* 500 uL S9 mix (for tests with metabolic activation) or S9 mix substitution buffer (for tests without metabolic activation)
* 100 uL bacteria suspension (cfr. precultures)
PRE-INCUBATION ASSAY (EXPERIMENT II):
In the pre-incubation assay 100 uL test solution, 500 uL S9 mix / S9 mix substitution buffer and 100 uL bacterial suspension were mixed in a test tube and shaken at 37°C for 60 minutes. After pre-incubation 2,0 mL overlay agar (45°C) was added to each tube. The mixture was poured on selective agar plates. - Evaluation criteria:
- ACCEPTABILITY OF THE ASSAY:
The Salmonella typhimurium and Escherichia coli reverse mutation assay is considered acceptable if it meets the following criteria:
- regular background growth in the negative and solvent control
- the spontaneous reversion rates in the negative and solvent control are in the range of the lab's historical data
- the positive control substance should produce a significant increase in mutant colony frequencies
EVALUATION OF RESULTS:
A test item is conisdered as a mutagen if a biologically relevant increase in the number of revertants exceeding the threshold of twice (for TA 98, TA 100 and WP2 uvrA) or thrice (for TA 1535 and TA 1537) the colony count of the corresponding solvent control is observed.
A dose dependent increase is considered biologically relevant if the threshold is exceeded at more than one concentration.
An increase exceeding the threshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment.
A dose dependent increase in the number of revertant colonies below the threshold is regarded as an indication of a mutagenic potential if reproduced in an independent second experiment. However, whenever the colony counts remain within the historical range of negative and solvent controls such an increase is not considered biologically relevant. - Statistics:
- /
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:
- for TA 1537 (as from 1000 ug/plate) and TA 100 (as from 2500 ug/plate)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- 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
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with and without metabolic activation
During the described mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used. - Executive summary:
An Ames study was performed to investigate the potential of dibutyl phenyl phosphate (DBPP) reaction mass to induce gene mutations in the plate incorporation test (experiment I) and the pre-incubation test (experiment II) using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100, and the Escherichia coli strain WP2 uvrA.
The assay was performed in two independent exerpiments both with and without liver microsomal activation. Each concentration, including the controls, was tested in triplicate. The test item was tested at the following concentrations in both experiment I and experiment II: 3 - 10 - 33 - 100 - 333 - 1000 - 2500 and 5000 ug/plate.
The plates incubated with the test item showed reduced background growth in all strains at higher concentrations.
Toxic effects, evident as a reduction in the number of revertants (below the indication factor of 0,5), occurred in nearly all strains with and without activation.
No substantial increase in revertant colony numbers of any of the 5 tester strains was observed following treatment with dibutyl phenyl phosphate (DBPP) reaction mass at any dose level, neither in the presence nor absence of metabolic activation mix (S9).
Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies.
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