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EC number: 947-922-8 | 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:
- 13 December 2017 to 09 February 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- In accordance with the OECD guideline for testing of chemicals No. 471 “Bacterial Reverse Mutation
Test”, adopted on 21st July 1997. - Deviations:
- no
- Principles of method if other than guideline:
- - Principle of test:
- Short description of test conditions:
- Parameters analysed / observed: - GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reaction products of alcohols, C11-14-iso, C13 rich and phosphorus pentoxide
- EC Number:
- 947-922-8
- Molecular formula:
- n.a. (UVCB)
- IUPAC Name:
- Reaction products of alcohols, C11-14-iso, C13 rich and phosphorus pentoxide
- Test material form:
- liquid
- Details on test material:
- clear yellowish liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:Clariant Produkte (Deutschland) GmbH,
- Expiration date of the batch: 2019-02-22
- Purity : 98.1%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Ambient (21 to 29°C)
- Solubility a test substance in the vehicle: Dimethly sulphoxide
OTHER SPECIFICS:
Method
- Target gene:
- Histidine Locus
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- 1 mL of S9 homogenate was mixed with 9 mL co factor
- Test concentrations with justification for top dose:
- On the basis of test item solubility, precipitation and initial cytotoxicity test 2 µL/plate was considered as the highest test concentration for mutation assay and other concentrations tested are 0.02, 0.06, 0.20, 0.63 µL/plate
- Vehicle / solvent:
- The test item was miscible in dimethyl sulphoxide at 50 µL/mL- Vehicle(s)/solvent(s) used:Dimethyl sulphoxide
- Justification for choice of solvent/vehicle:The test item was miscible in dimethyl sulphoxide at 50 µL/mL.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- mitomycin C
- other: 2-Aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation); preincubation; in
DURATION
- Preincubation period: 30 Minutes
NUMBER OF REPLICATIONS: Triplicates
CYTOTOXICITY :cytotoxicity by lawn evaluation & mutation assay by counting revertant colonies. - Rationale for test conditions:
- Not applicable
- Evaluation criteria:
- The test will be judged positive if the increase in mean revertants at the peak of the dose response is equal to or greater than 2 times the mean vehicle control value in Salmonella typhimurium strains TA98, TA100 and TA102 or equal to or greater than 3 times the mean vehicle control value in tester strains TA1535 and TA1537.
- Statistics:
- Not applicable
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: Insoluble in water
- Precipitation: The test item resulted in mild precipitation at 5 and 4 µL/plate, minimal precipitation at 3 µL/plate and no precipitation up to 2 µL/plate
HISTORICAL CONTROL DATA (with ranges, means and standard deviation and confidence interval (e.g. 95%)
- Positive historical control data:
Plate incorporation method (WITH S9)
Tester Strain TA98 TA100 TA1535 TA 537 TA102
Mean 412. 0 385.5 143.2 118.2 606.2
±SD 21.7 20.9 9.6 8.7 27.6
Min 280 306 117 100 510
Max 440 419 292 149 670
Plate incorporation method (WITHOUT S9)
Tester Strain TA98 TA100 TA1535 TA 537 TA102
Mean 399.7 378.3 145.0 120. 2 613.4
±SD 36.2 23.9 12.6 8.5 22.6
Min 310 311 112 103 589
Max 428 446 190 158 694
Pre incubation method (WITH S9)
Tester Strain TA98 TA100 TA1535 TA1537 TA102
Mean 410.1 386.0 144.2 117.1 606.5
±SD 18.2 22.0 11.3 6.5 26.7
Min 290 298 103 102 508
Max 428 425 187 128 670
Pre incubation method (WITHout S9)
Tester Strain TA98 TA100 TA1535 TA1537 TA102
Mean 404.0 379.1 146.5 118.7 616.0
±SD 29. 0 23.7 14.5 5.5 25.9
Min 314 317 110 105 590
Max 428 450 200 134 699
Applicant's summary and conclusion
- Conclusions:
- Based on the results obtained from the study, it is concluded that the test item, is “non-mutagenic” in the Bacterial Reverse Mutation Test up to the highest tested concentration 2 µL/plate under the test conditions
- Executive summary:
The test item was evaluated for mutagenicity in Bacterial Reverse Mutation Test as per the OECD guidelinefor testing of chemicalsNo. 471, “Bacterial Reverse Mutation Test”, adopted on21stJuly 1997.
On the basis of test item solubility and precipitation tests, the initial cytotoxicity test was performed at 0.5, 0.6, 0.7, 0.8, 0.9, 1, 2, 3, 4 and 5µL/plate. Initial cytotoxicity test was performed withSalmonella typhimuriumTA100 both in the presence and absence of metabolic activation system.
The tester strain,Salmonella typhimuriumTA100 treated with test item in the presence and absence of metabolic activation system resulted in cytotoxicity and it was observed by a thinning of the bacterial background lawn. Those concentrations are graded as 1+(extremely reduced lawn) for 4 and5µL/plate,2+(moderately reduced lawn) for3µL/plate and 3 + (Slightly reduced lawn)for 2 µL/platewhen compared to vehicle control.
On the basis of cytotoxicity results 2 µL/plate was considered as the highest test concentration for mutation assay.
The test concentrations tested in the mutation assay were selected based on the results of solubility, precipitation and initial cytotoxicity test. The two independent trials (trial 1 and 2) were conducted by plate incorporation method and pre incubation method in the presence and absence of metabolic activation system. In mutation assay the test item was tested at the concentrations of 0.02, 0.06, 0.20, 0.63 and 2µL/plate. Vehicle control (dimethyl sulphoxide) and appropriate positive controls (2-nitrofluorene, sodium azide and 9-Aminoacridine, Mitomycin C for trials “without metabolic activation” and 2-Aminoanthracene for trials “with metabolic activation”) were tested simultaneously.
The tester strains used in the mutation assay wereSalmonella typhimuriumTA98, TA100, TA102, TA1535 and TA1537.
Based on the experimental results obtained, the mean numbers of revertant colonies at the tested concentrations were comparable to those of the vehicle control, in both the trials, in the presence and absence of metabolic activation. There was no appreciable increase in number of revertant colonies at any of the tested concentrations in both the trials.
The number of revertant colonies in the positive controls resulted in 2.2 to 14.7 fold increase under identical conditions.
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