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EC number: - | 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
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- 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
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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:
- Jan 9 2018 - Feb 29 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reaction mass of 1-hydroxypropan-2-yl diethylphosphinate and 2-hydroxypropyl diethylphosphinate
- Cas Number:
- 2230512-72-6
- Molecular formula:
- C7H17O3P
- IUPAC Name:
- Reaction mass of 1-hydroxypropan-2-yl diethylphosphinate and 2-hydroxypropyl diethylphosphinate
- Test material form:
- liquid
- Details on test material:
- R&D level
Constituent 1
- Specific details on test material used for the study:
- composition 100%
Clear transparent liquid
The test substance was expected to be stable for the duration of the test
Expiration date: November 3, 2020
Method
- Target gene:
- S. typhimurium: histidine
E. coli: tryptophan
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- other: TA1535: rfa, uvrB; 1537: rfa, uvrB; 98: rfa, uvrB, R-factor; 100: rfa, uvrB, R-factor
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- other: uvrA
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix (cofactor supplemented post-mitochondrial fraction) sourced from mate Sprague-Dawley rats induced with phenobarbital and benzoflavone.
- Test concentrations with justification for top dose:
- The test was conducted with E17-194T at levels of 1.58, 5, 15.8, 50, 158, 500, 1580 and 5000 microgram per plate, with the high level being the standard limit for this test.
- Vehicle / solvent:
- sterile water
Controls
- Untreated negative controls:
- yes
- Remarks:
- Test material not incorporated
- Negative solvent / vehicle controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- methylmethanesulfonate
- other: Daunomycin ; 2-Aminoanthracene
- Details on test system and experimental conditions:
- The initial test followed the plate incorporation method, in which the following materials were mixed and poured over the surface of minimal agar plate:
10 microliter of prepared test substance, negative (vehicle) control, or prepared positive control substance.
500 microliter S9 mix or substitution buffer
100 microliter bacteria suspension (ST or EC)
2000 microliter overlay agar maintained at approx. 45 degrees C
Plates were prepared in triplicate at each experimental point and uniquely identified. after pouring, plates were placed on a level surface until the agar gelled then inverted and incubated at approx. 37 degrees C until growth was adequate for enumeration (approx 65 hours). appropriate sterility control check plates (treated with critical components in the absence of bacteria) were incubated as a standard procedural check. For the bacterial strains, plates were prepared for each treatment as follows (see table 1 below).
Conformatory test: this test employed the pre-incubation modification of the plate incorporation test. The test or control substances, bacteria suspension and S9/substitution buffer were incubated under agitation for approximately 30 minutes at approx. 37 degrees C prior to mixing with the overlay agar and pouring onto the minimal agar plates before proceeding as described for the initial test. The atudy design for the confirmatory test, including strains, dose levels ect. was as described above for the initial test.
A supplemental test wes performed to clarify results obtained with TA1537 in the initial phase of testing. The study utilized the same methodolgies and dose levels described above in the original phase of testing. Appropriate vehicle and positive controls were included. - Rationale for test conditions:
- The background lawn for vehicle control plates should appear normal. The mean revertant colony counts for each strain treated with the vehicle should lie close to or within the expected range taking into account the laboratory historical control range / or published values. The positive controls (with S9 where required) should produce substantial increases in revertant colony numbers with the appropriate bacterial strain as specified below.
- Evaluation criteria:
- Evalation of Toxicity: Toxic effects of the test substance are indicated by the partial or complete absence of a background lawn of the non-revertant bacteria or a substantial dose-related reduction in revertant colony counts compared with lower dose levels and concurrent vehicle control taking into account the laboratory historical control range. Where precipitation obscures observations on the condition of the background lawn, the lawn can be considered normal and intact if the revertant colony counts are within the expected range based on results for lower dose levels and historical counts for that strain.
Evaluation of Mutagenicity: For each experiment point, the mutation factor (MF) was calculated by dividing the mean revertant colony count by the mean revertant colony count for the corresponding concurrent vehicle control group. The mutagenic activity of the test item was assessed by applying the following criteria:
Positive results (mutagenic potential): The results for the test item showed a substantial increase in revertant colony counts, i.e., response MF ≥ 2 for strains TA98, TA 100 and WP2 uvrA or MF ≥ 3 for strains TA1535 and TA 1537, with mean value(s) outside the laboratory historical control range. Otherwise, results were considered negative.
The above increae must be dose related and/or reproducible, i.e., increses must be obtained at more than one experimental point. if this criteria is not met, the results may be classified as equivocal and further testing may be appropriate.
A test substance that produces neither a concentration related increase in the number of revertant colonies nor a reproducible substantial increase in revertant colonies to be non-mutagenic in this test system.
- Statistics:
- means and standard deviations for all quantitative data were collected by the lab.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Remarks:
- pre incorporation method-main test
- 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
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Remarks:
- pre-incubation method- confirmatory test
- 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
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Remarks:
- plate incorporation method-supplemental main test 1
- 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
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Remarks:
- pre-incubation method-supplemental confirmatory test 1
- 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
- Key result
- Species / strain:
- S. typhimurium TA 98
- Remarks:
- plate incorportaion method - main test
- 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
- Key result
- Species / strain:
- S. typhimurium TA 98
- Remarks:
- pre-incubation method - confirmatory test
- 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
- Key result
- Species / strain:
- S. typhimurium TA 100
- Remarks:
- plate incorporation method - main test
- 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
- Key result
- Species / strain:
- S. typhimurium TA 100
- Remarks:
- pre-incubation method-confirmatory test
- 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
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Remarks:
- plate incorporation method - main test
- 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
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Remarks:
- pre-incubation method - confirmatory test
- 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
- Additional information on results:
- The mean revertant colony counts for each strain treated with the vehicle were close to or within the expected range, considering the laboratory historical control range and/or published values. The positive control substances caused the expected substantial increses in revertant colony counts in both absence and presence of S9 mix.
No signs of precipitation or contamination were noticed in any of the strains at all dose levels. No signs of toxicity were seen in any of the strains in any dose levels.
There was no contamination-related or substantial test substance related increases in the number of revertant colonies observed with all strains tested in both in the absence and presence of S9 using either plate incorporation or the pre incubation method - Remarks on result:
- other: not mutagenic
Applicant's summary and conclusion
- Conclusions:
- Based on these findings and on evaluation system used E17-194T did not elicit evidence of bacterial mutagenicity in the Ames assay.
- Executive summary:
Ames test was conducted with E17 -194T at levels of 1.58, 5.0, 15.8, 50, 158, 500, 1580 and 5000 microgram/plate. The main test was conducted using the plate incorporation method in both the absence and presence of metabolic activation. The results of the test were confirmed using a similar study design but employing the pre-incubation modification of the Ames test.
The mean revertant colony counts for each strain treated with the vehicle were close to or within the expected range, considering the laboratory historical control range and/or published values. The positive control substances caused the expected substantial increses in revertant colony counts in both absence and presence of S9 mix.
No signs of precipitation or contamination were noticed in any of the strains at all dose levels. No signs of toxicity were seen in any of the strains in any dose levels.
There was no contamination-related or substantial test substance related increases in the number of revertant colonies observed with all strains tested in both in the absence and presence of S9 using either plate incorporation or the pre incubation method.
Based on these findings and on evaluation system used E17-194T did not elicit evidence of bacterial mutagenicity in the Ames assay.
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