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EC number: 701-118-1 | CAS number: 2156592-54-8
- 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
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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:
- 2011-05-05 until 2011-07-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, well-performed and well-documented
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 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
- Principles of method if other than guideline:
- first experiment 4 hours treatment with and without metabolic activation
second experiment 24 hours treatment without metabolic activation, 4 hours treatment with metabolic activation - GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- 6-(3-tetrapropenyl-2,5-dioxopyrrolidin-1-yl)hexanoic acid
- EC Number:
- 800-770-5
- Cas Number:
- 1424148-99-1
- Molecular formula:
- C22H39NO4
- IUPAC Name:
- 6-(3-tetrapropenyl-2,5-dioxopyrrolidin-1-yl)hexanoic acid
- Details on test material:
- Identity: (Tetrapropylensuccinimido)-capronsäure
Batch No.: ESD0009058
Molecular Weight: 379.54
Purity: >97.5%, dose calculation was adjusted to purity
Stability in Solvent: Not indicated by the sponsor
Storage: At room temperature
Expiration Date: March 29, 2013
On the day of the experiment (immediately before treatment), the test item was dissolved in DMSO (purity 99.9 %). The final concentration of DMSO in the culture medium was 0.5 % (v/v). The solvent was chosen to its solubility properties and its relative non-toxicity to the cell cultures.
Constituent 1
Method
- Target gene:
- 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
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: yes
- Periodically "cleansed" against high spontaneous background: yes
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital/Beta-Naphtoflavone induced Rat liver S9
- Test concentrations with justification for top dose:
- Experiment I:
without S9 mix 1.9; 3.8; 7.5; 15.0; 22.5; 30.0 µg/mL
with S9 mix: 15.0; 30.0; 60.0; 120.0; 180.0; 240.0 µg/mL
Experiment II:
without S9 mix: 15.0; 30.0; 60.0; 120.0; 160.0; 200.0 µg/mL
with S9 mix: 30.0; 60.0; 120.0; 160.0; 180.0; 200.0 µg/mL
In the first experiment the cultures at the lowest concentration without metabolic activation was not continued since a minimum of only four analysable concentrations is required by the guidelines. The cultures at the highest concentration with metabolic activation were not continued due to exceedingly severe cytotoxic effects. In the second experiment the cultures at the two highest concentrations without metabolic activation and the highest concentration with metabolic activation were not continued due to exceedingly cytotoxic effects. - Vehicle / solvent:
- DMSO
Justification for choice of solvent/vehicle: solubility properties
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 7,12-dimethylbenzanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: Experiment I: 4 hours with and without metabolic activation, Experiment II: 24 hours without metabolic activation, 4 hours with metabolic activation
- Expression time (cells in growth medium): 72 hours
- Selection time (if incubation with a selection agent): 10 days
SELECTION AGENT (mutation assays): 6-Thioguanine
NUMBER OF REPLICATIONS: 2
NUMBER OF CELLS EVALUATED: >1,5x10exp. 6
DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency - Evaluation criteria:
- A test item producing neither a concentration-related increase of the mutant frequency nor a reproducible positive response at any of the test points is considered to be non-mutagenic in this system.
A mutagenic response is described as follows:
The test item is classified as mutagenic if it induces reproducibly with one of the concen¬trations a mutation frequency that is three times higher than the spontaneous mutation fre¬quency in the experiment.
The test item is classified as mutagenic if there is a reproducible concentration-related increase of the mutation frequency. Such evaluation may be considered also in the case that a threefold increase of the mutant frequency is not observed.
In a case by case evaluation this decision depends on the level of the correspon¬ding solvent control data. - Statistics:
- A linear regression (least squares) was performed to assess a possible dose dependent increase of mutant frequencies. The number of mutant colonies obtained for the groups treated with the test item were compared to the solvent control groups. A trend is judged as significant whenever the p-value (probability value) is below 0.05. However, both, biological and statistical significance were considered together.
Results and discussion
Test results
- Key result
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: Not effected
- Effects of osmolality: Not increased
- Evaporation from medium: Not examined
- Water solubility: Not indicated by the sponsor
- Precipitation:
Pre-experiment: Precipitation occurred at 475.0 µg/mL and above in the presence and absence of metabolic activation after 4 hours treatment. Following continuous treatment for 24 hours without metabolic activation, precipitation was observed at the maximum concentration of 950 µg/mL.
Experiment I and II: No precipitation observed.
- Other confounding effects: None
RANGE-FINDING/SCREENING STUDIES:
In the range finding pre-experiment test item concentrations between 29.7 µg/mL and 3800 µg/mL (≈10 mM) were used to evaluate toxicity in the presence (4 hours treatment) and absence (4 hours and 24 hours treatment) of metabolic activation.
Strong toxic effects were observed at 59.4 µg/mL and above in the absence of metabolic activation and at 237.5 µg/mL and above with metabolic activation (4 hours treatment). Following continuous treatment (24 hours) strong toxic effects occurred at 237.5 µg/mL and above.
The test medium was checked for precipitation or phase separation at the end of each treatment period (4 or 24 hours) prior to removal to the test item. Precipitation occurred at 475.0 µg/mL and above in the presence and absence of metabolic activation after 4 hours treatment. Following continuous treatment for 24 hours without metabolic activation, precipitation was observed at the maximum concentration of 950 µg/mL.
In the pre-experiment the highest concentration was neutralised with 2 N sodium hydroxide. There was no relevant shift of osmolarity of the medium even at the maximum concentration of the test item.
Based on the results of the pre-experiment, the individual concentrations of the main experiments were selected. A series of concentrations spaced by a factor of 2 was placed into the lower range. Narrower spacing was used at high concentrations to cover the toxic range more closely.
COMPARISON WITH HISTORICAL CONTROL DATA: Complies
ADDITIONAL INFORMATION ON CYTOTOXICITY:
Relevant cytotoxic effects defined as a reduction of the relative cloning efficiency I and/or relative cell density to values below 50% in both parallel cultures were noted in the first experiment at 30.0 µg/mL without metabolic activation and at 180 µg/mL and above with metabolic activation. In the second experiment cytotoxic effects as described above occurred again at 180 µg/mL and above with metabolic activation. In the absence of metabolic activation cytotoxicity was noted at 120 µg/mL and above in culture I and at 200 µg/mL in culture II. The recommended toxic range of a relative cloning efficiency or a relative cell density of approximately 10-20% was covered by at least one of the parallel cultures with and without metabolic activation.
Any other information on results incl. tables
Summary Table
relative | relative | relative | mutant | relative | relative | relative | mutant | |||||
conc. | S9 | cloning | cell | cloning | colonies/ | induction | cloning | cell | cloning | colonies/ | induction | |
µg/mL | mix | efficiency I | density | efficiency II | 106cells | factor | efficiency I | density | efficiency II | 106cells | factor | |
% | % | % | % | % | % | |||||||
Column | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 |
Experiment I / 4 h treatment | culture I | culture II | ||||||||||
Solvent control with DMSO | - | 100.0 | 100.0 | 100.0 | 9.2 | 1.0 | 100.0 | 100.0 | 100.0 | 42.0 | 1.0 | |
Positive control (EMS) | 150.0 | - | 78.7 | 96.4 | 89.4 | 142.0 | 15.5 | 95.7 | 74.3 | 94.4 | 164.7 | 3.9 |
Test item | 1.9 | - | 96.7 | culture was not continued# | 98.0 | culture was not continued# | ||||||
Test item | 3.8 | - | 92.6 | 75.7 | 99.7 | 19.2 | 2.1 | 93.5 | 64.3 | 107.9 | 21.7 | 0.5 |
Test item | 7.5 | - | 100.6 | 86.8 | 77.0 | 48.4 | 5.3 | 94.6 | 85.8 | 105.1 | 15.8 | 0.4 |
Test item | 15.0 | - | 102.3 | 80.4 | 81.4 | 27.4 | 3.0 | 94.1 | 60.1 | 112.3 | 29.7 | 0.7 |
Test item | 22.5 | - | 77.6 | 82.3 | 102.3 | 24.1 | 2.6 | 83.3 | 91.1 | 103.5 | 32.5 | 0.8 |
Test item | 30.0 | - | 30.3 | 17.1 | 86.5 | 58.7 | 6.4 | 34.5 | 38.7 | 97.1 | 37.7 | 0.9 |
Solvent control with DMSO | + | 100.0 | 100.0 | 100.0 | 17.1 | 1.0 | 100.0 | 100.0 | 100.0 | 14.3 | 1.0 | |
Positive control (DMBA) | 1.1 | + | 67.5 | 37.1 | 60.9 | 763.9 | 44.5 | 63.6 | 72.1 | 65.9 | 1012.5 | 70.9 |
Test item | 15.0 | + | 93.5 | 96.4 | 101.3 | 11.1 | 0.6 | 90.8 | 169.6 | 97.4 | 12.3 | 0.9 |
Test item | 30.0 | + | 90.0 | 115.5 | 97.2 | 10.9 | 0.6 | 97.9 | 153.9 | 64.9 | 27.3 | 1.9 |
Test item | 60.0 | + | 99.7 | 86.9 | 108.5 | 11.1 | 0.6 | 89.6 | 196.1 | 70.1 | 26.3 | 1.8 |
Test item | 120.0 | + | 93.3 | 112.3 | 96.3 | 8.9 | 0.5 | 113.2 | 157.0 | 104.3 | 24.1 | 1.7 |
Test item | 180.0 | + | 0.0 | 17.5 | 41.1 | 0.0 | 0.0 | 0.0 | 30.5 | 61.3 | 26.1 | 1.8 |
Test item | 240.0 | + | 0.0 | culture was not continued## | 0.0 | culture was not continued## | ||||||
Experiment II / 24 h treatment | culture I | culture II | ||||||||||
Solvent control with DMSO | - | 100.0 | 100.0 | 100.0 | 5.3 | 1.0 | 100.0 | 100.0 | 100.0 | 10.9 | 1.0 | |
Positive control (EMS) | 150.0 | - | 83.1 | 101.8 | 74.9 | 221.3 | 41.9 | 83.0 | 95.2 | 78.3 | 253.8 | 23.3 |
Test item | 15.0 | - | 98.0 | 107.4 | 91.9 | 6.8 | 1.3 | 98.1 | 104.8 | 99.1 | 8.8 | 0.8 |
Test item | 30.0 | - | 97.5 | 84.5 | 81.4 | 13.1 | 2.5 | 97.1 | 87.8 | 93.5 | 13.3 | 1.2 |
Test item | 60.0 | - | 88.4 | 95.6 | 88.0 | 14.7 | 2.8 | 90.0 | 98.3 | 97.4 | 10.2 | 0.9 |
Test item | 120.0 | - | 86.2 | 44.8 | 88.2 | 10.0 | 1.9 | 88.8 | 84.3 | 95.1 | 14.6 | 1.3 |
Test item | 160.0 | - | 89.3 | 1.3 | culture was not continued## | 85.9 | 89.7 | 96.8 | 19.2 | 1.8 | ||
Test item | 200.0 | - | 0.0 | 6.6 | culture was not continued## | 0.0 | 3.0 | culture was not continued## | ||||
Experiment II / 4 h treatment | ||||||||||||
Solvent control with DMSO | + | 100.0 | 100.0 | 100.0 | 11.4 | 1.0 | 100.0 | 100.0 | 100.0 | 12.0 | 1.0 | |
Positive control (DMBA) | 1.1 | + | 59.0 | 133.4 | 48.4 | 1797.0 | 158.3 | 52.7 | 123.9 | 71.9 | 1345.2 | 112.1 |
Test item | 30.0 | + | 96.8 | 114.6 | 92.4 | 15.4 | 1.4 | 97.4 | 129.3 | 109.7 | 16.8 | 1.4 |
Test item | 60.0 | + | 116.5 | 111.5 | 83.6 | 5.6 | 0.5 | 107.2 | 118.6 | 108.9 | 17.9 | 1.5 |
Test item | 120.0 | + | 95.8 | 125.9 | 88.1 | 7.6 | 0.7 | 93.4 | 105.8 | 87.2 | 10.1 | 0.8 |
Test item | 160.0 | + | 15.8 | 58.2 | 83.9 | 16.1 | 1.4 | 51.2 | 106.9 | 97.2 | 15.7 | 1.3 |
Test item | 180.0 | + | 8.0 | 36.4 | 82.7 | 18.3 | 1.6 | 24.7 | 108.3 | 95.5 | 22.9 | 1.9 |
Test item | 200.0 | + | 0.0 | culture was not continued## | 0.4 | culture was not continued## |
# culture was not continued since a minimum of only four analysable concentrations is required
## culture not continued due to exceedingly strong toxic effects
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The mutagenic potential of (Tetrapropenyl succinimido)-caproic acid was investigated according to the OECD Guideline 471. No mutagenic property was found. - Executive summary:
The mutagenic potential of (Tetrapropenyl succinimido)-caproic acid was investigated according to the OECD Guideline 476. No mutagenic property was found.
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