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EC number: 800-765-8 | CAS number: 1424149-03-0
- 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 mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011-11-07 to 2012-04-04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline Study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.17 (Mutagenicity - In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5300 - In vitro Mammalian Cell Gene Mutation Test
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- (Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, Germany)
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- sodium/triethanolamine 4-((2-hydroxyethyl)amino)-3-pentaproenyl-4-oxobutanoate
- EC Number:
- 800-765-8
- Cas Number:
- 1424149-03-0
- Molecular formula:
- C21H40NO4.1/2Na.1/2C6H15NO3
- IUPAC Name:
- sodium/triethanolamine 4-((2-hydroxyethyl)amino)-3-pentaproenyl-4-oxobutanoate
- Details on test material:
- Name: Pentapropylensuccinic anhydride, reaction products with ethanolamine, sodium and triethanolamine salts
Chemical Name: Pentapropylensuccinic anhydride, reaction products with ethanolamine, sodium and triethanolamine salts
Batch No.: ESD0010887
Expiry Date: 13.12.2012
Physical state at RT: Liquid
Colour: Brown
Active Components: 82.4% (17.6 % Water)
Density: 1.087 g/cm3
pH: 9.0 (1 % in water)
Boiling Point (C): 107 C
Stability: Stable
Storage Conditions: Room Temperature
Constituent 1
Method
- Target gene:
- hypoxanthine-guanine-phosphoribosyl-transferase (HPRT)
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- -Type and identity of media: MEM
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically "cleansed" against high spontaneous background: yes
- Metabolic activation:
- with and without
- Metabolic activation system:
- Liver S9 of Wistar Phenobarbital and ß-Naphthoflavone-induced rat liver S9 mix
- Test concentrations with justification for top dose:
- Pre-experiment for experiment I (with and without metabolic activation):
5, 20, 100, 500, 1500, 3000, 5000 µg/mL
Pre-experiment for experiment II (only without metabolic activation, 20 h long-term exposure assay):
50, 75, 100, 125, 150, 175 µg/mL
Experiment I
without metabolic activation: 1.0, 2.5, 10.0 14.0, 16.0, 18.0, 20.0, 22.0 and 24.0 µg/mL
and with metabolic activation: 100, 120, 140, 180, 190, 210, 215, 225 and 235 µg/mL
Experiment II
without metabolic activation: 2.5, 10.0, 25.0, 50.0, 75.0, 100.0, 115.0 and 130.0 µg/mL
and with metabolic activation: 75.0, 100.0, 125.0, 175.0, 182.5, 190.0, 197.5, 205.0 and 212.5 µg/mL - Vehicle / solvent:
- Vehicle (Solvent) used: cell culture medium (MEM + 0% FBS 4h treatment; MEM + 10% FBS 20h treatment)
The test item was dissolved in cell culture medium, processed by stirring for 10 min and diluted prior to treatment. All concentrations used referred to the active component of the test item (correction factor 1.214)
Controlsopen allclose all
- Untreated negative controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- without metabolic activation
Migrated to IUCLID6: 300 µg/mL
- Positive control substance:
- 7,12-dimethylbenzanthracene
- Remarks:
- with metabolic activation
Migrated to IUCLID6: 1 µg/mL and 1.5 µg/mL
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: dissolved in medium
DURATION: 4 h (short-term exposure), 20 h (long-term exposure)
Expression time (cells in growth medium): 48-72 h
Selection time (if incubation with selection agent): about one week
SELECTION AGENT ( mutation assay) 11 µg/mL 6-thioguanine (TG)
NUMBER OF REPLICATIONS: two separate experiments (I+II) with single exposure; 5 individual flasks were seeded and evaluated
NUMBER OF CELLS EVALUATED: 400000 cells per flask
DETERMINATION OF CYTOTOXICITY: Method: relative growth - Evaluation criteria:
- A test is considered to be negative if there is no biologically relevant increase in the number of mutants.
There are several criteria for determining a positive result:
-a reproducible three times higher mutation frequency than the solvent control for at least one of the concentrations;
-a concentration related increase of the mutation frequency; such an evaluation may be considered also in the case that a three-fold increase of
the mutant frequency is not observed;
-if there is by chance a low spontaneous mutation rate in the corresponding negative and solvent controls a concentration related increase of the mutations within their range has to be discussed.
Results and discussion
Test results
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (Experiment I without S9: ≥ 18.0 μg/mL; experiment I with S9: ≥ 140 μg/mL; Experiment II without S9: ≥ 100.0 μg/mL; Experiment II with S9:≥ 182.5 μg/mL
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
In a mammalian cell gene mutation assay (HPRT locus),V79cells culturedin vitrowere exposed toPentapropylensuccinic anhydride, reaction products with ethanolamine, sodium and triethanolamine saltsdissolved incell culture medium (MEM + 0% FBS 4h treatment; MEM + 10% FBS 20h treatment)at concentrations of
-1.0, 2.5, 10.0 14.0, 16.0, 18.0, 20.0, 22.0 and 24.0 µg/mL(without metabolic activation, Experiment I)
-100, 120, 140, 180, 190, 210, 215, 225 and 235 µg/mL(with metabolic activation, Experiment I)
-2.5, 10.0, 25.0, 50.0, 75.0, 100.0, 115.0 and 130.0 µg/mL(without metabolic activation, Experiment II)
-75.0, 100.0, 125.0, 175.0, 182.5, 190.0, 197.5, 205.0 and 212.5 µg/mL(with metabolic activation, Experiment II).
Pentapropylensuccinic anhydride, reaction products with ethanolamine, sodium and triethanolamine saltswas testedup to cytotoxic concentrations.
In experiment I without metabolic activation the relative growth was 24.8% for the highest concentration (24.0 µg/mL) evaluated. The highest biologically relevant concentration evaluated with metabolic activation was 235 µg/mL with a relative growth of 14.3%.In experiment II without metabolic activation the relative growth was 16.0% for the highest concentration (130.0 µg/mL) evaluated. The highest concentration evaluated with metabolic activation was 212.5 µg/mL with a relative growth of 17.2%..
In experiment I without metabolic activation the highest mutation rate (compared to the negative control values) of 1.70 was found at a concentration of 16.0 µg/mL with a relative growth of 90.7%.
In experiment I with
metabolic activation the highest mutation rate (compared to the negative
control values) of 1.51 was found at a concentration of 215 µg/mL with a
relative growth of 21.7%.
In experiment II without metabolic activation the highest mutation rate
(compared to the negative control values) of 1.07 was found at a
concentration of 75.0 µg/mL with a relative growth of 78.2%.
In experiment II with metabolic activation the highest mutation rate
(compared to the negative control values) of 2.03 was found at a
concentration of 197.5 µg/mL with a relative growth of 31.4%.
The positive controlsdidinduce the appropriate response.
There wasno evidence of a concentration related positive responseof induced mutant colonies over background.
This study is classified asacceptable. This study satisfies the requirement for Test Guideline OPPTS 870.5300, OECD 476 forin vitromutagenicity (mammalian forward gene mutation) data.Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Pentapropylensuccinic anhydride, reaction products with ethanolamine, sodium and triethanolamine salts is non-mutagenic in the HPRT locus using V79 cells of the Chinese Hamster. - Executive summary:
Pentapropylensuccinic anhydride, reaction products with ethanolamine, sodium and triethanolamine salts is investigated for its mutagenic potential according to the OECD Guideline 476 (HPRT). No mutagenic effect was found.
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