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EC number: 931-105-8 | 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:
- 03/2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reaction mass of L-isoleucine and octadecan-1-ol and ethanesulphonic acid and docosan-1-ol
- EC Number:
- 931-105-8
- Cas Number:
- 1156505-34-8
- Molecular formula:
- C26-30H56-64O5NS
- IUPAC Name:
- Reaction mass of L-isoleucine and octadecan-1-ol and ethanesulphonic acid and docosan-1-ol
- Test material form:
- solid: flakes
Constituent 1
Method
- Target gene:
- see report
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- S. typhimurium TA 97
- Remarks:
- a
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- S. typhimurium TA 98
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- S. typhimurium TA 100
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- S. typhimurium TA 102
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9
- Test concentrations with justification for top dose:
- test article was diluted in ethanol 95% and tested at the following concentation per plate: 5mg, 1.6mg, 0.5mg, 0.16mg, 0.05mg and 0.016mg/plate. The concentrations tested were based on the OECD 471 recommended concentrations for non-cytotoxic compounds that are not soluble at 5 mg/plate. The highest concentration tested (2.0mg/plate) was not completely soluble.
- Vehicle / solvent:
- Ethanol
Controls
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Ethanol
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- mitomycin C
- other: 2-aminoflurone and 2-aminoanthracene
- Details on test system and experimental conditions:
- Broth Culture preparation:
Commercial culture disc were used to inoculate nutrient broth for testing. The cultures were incubated
at 37C for 10-14 hrs on an orbital shaker until when measured spectrochemically at 660nm, an abs
orbance reading of approximately 1.0 to 2.0 was obtained. Validation data of the cultures showed ab
sorbance readings int he above range resulted in concentrations of approximately 10^9 CFU/mL.
Strain genotype verification
the culture disc lot numbers used were checked for presence of appropriate strain genotype c
haracteristics. These tests included verification of the following:
- presense of uvrB mutation
- presence or absence of R-factor plasmid
-presence of rfa mutation
requirement for histidine
The uvrB mutation was verified by demonstrating UV sensitivity (lack of repair system). The R-factor
was checked by determining sensitivity or resistance to ampicillin (0.08% in 0.02 NaOH. The pres
ense of the rfa mutation was verified by demonstrating sensitivity to crystal violet (0.1% in water) on
nutrient agar plates. The histidine requirement was assured by plating onto minimal glucose agar
plates spread with 0.1mL of 0.5 mM biotin and both with and without 0.1 M histidine.
Metabolic activation system
The S-9 activation system was used to screen for the presense of mutagens from byproducts of the
test sample. Rat liver S-9 homogenate was obtained from Moleculat Toxicology Inc. The homoenate
was kept frozen at <-60C upon receipt. Plates requiring activation contained approximately 20microL
rat liver S-9 per plate. When working with soft agar, the plates did not exceed 47C
Top agar preparation
Aliquots of top agar were melted and maintained at 45C. Each 100 mL aliquot of top agar was fortified
with 5-10 mL of 0.5mM biotin and 0.%mM histidin prior to use.
Plate incorporation tests;
the test sample, solvent control and chemical controls were tested both with and without S-9 activa
tion. Sterile 13x100 mm test tubes were transferred to a waterbath held at 45. two mL aliquots of top
agar were transferred to each test tube. Three replicates of each of the materials were prepared and
the test organis and materials were added as follows:
three replicates for the solvent control with 100 microL solvent control.
three replicates for the each sample concentration with 100 microL test organism plus 100microL
sample
Three test tubes for each chemical control with 100 microL test organism plus 10 microL chemical control. Each replicate requiring S-9 activation had 0.5mL ot the prepared S-9 mix added. The replicates were vortexed, poured onto MGPA plates, swirled to form an even layer and allowed to solidify. The plates were incubated for growth at 37C for 48-72 hrs.
Spot tests
the sample was also analysed using spot method on plates with and without the activation system. T
wo mL aliquots of the top agar mixture and 0.1 mL of the appropriate test organism was added to min
imal glucose agar plates. The plates were allowed to harden then 10 microL of the sample was added
as a spot on the surface of the plate. The plates were incubated for growth of the organisms at 37C
for 48-72 hrs. only the highest sample concentration was tested using the spot method.
Chemical control materials
sodium azide,
mitomycin-C,
4-nitro-0-phenylene-diamine (NPD),
2-aminofluorene (2AF)
The chemical controls were tested using the plate incorporation method only.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- for all concentrations tested
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- for all concentrations tested
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- for all concentrations tested
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- for all concentrations tested
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 97
- Remarks:
- a
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- for all concentrations tested
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- The sample concentration tested did not meet the criteria for a potential mutagen
- Executive summary:
The AMES test is used to determine the potential mutagenic activity of the test sample. The test sample
did not produce a two-fold increase in the number of revertants or a clear dose related response in
any of the five tester strains. The spot plates showed a clear zone at the inoculation site indicating that
the sample was toxic to the bacteria but was not surrounded by a ring of increased reversion which
indicates the sample was not mutagenic. In summary, the sample concentration tested did not meet the
criteria for a potential mutagen
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