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EC number: 700-064-6 | CAS number: 2105830-60-0
- 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:
- 2017-09-07 to 2017-10-18
- 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 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
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- (Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, Germany)
- Type of assay:
- in vitro mammalian cell gene mutation test using the Hprt and xprt genes
Test material
- Reference substance name:
- Esterification product of castor oil and tetrahydromethyl-1,3-isobenzofuranedione
- EC Number:
- 700-064-6
- Cas Number:
- 2105830-60-0
- Molecular formula:
- Not applicable as this is a UVCB substance
- IUPAC Name:
- Esterification product of castor oil and tetrahydromethyl-1,3-isobenzofuranedione
- Test material form:
- liquid: viscous
- Details on test material:
- - Name: Cyclohexene-1,2-dicarboxylic acid, methyl-, castor-oil alkyl esters
- Product Name: Multiester P97-463
- CAS No.: 2105830-60-0
- Batch No.: X24Jan17
- Physical State: viscous liquid
- Colour: amber
- Density: 1.06 g/cm³
- Active Components: 94%
- Expiry Date: 31 December 2018
- Storage Conditions: Room temperature, protected from light and kept in closed container to avoid air contact
- Safety Precautions: The routine hygienic procedures were sufficient to assure personnel health and safety.
Constituent 1
Method
- Target gene:
- HPRT gene
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:
- 0.01, 0.02, 0.05, 0.10, 0.15, 0.20, 0.25 and 0.5 mg/mL
- Vehicle / solvent:
- DMSO (1%; v/v)
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 7,12-dimethylbenzanthracene
- ethylmethanesulphonate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: suspended in medium
DURATION: 4 h (short-term exposure)
Expression time (cells in growth medium): 7 - 9 days
Selection time (if incubation with selection agent): approximately 9 - 11 days
SELECTION AGENT ( mutation assay) 11 µg/mL 6-thioguanine (TG)
NUMBER OF REPLICATIONS: one experiments with single exposure; cells were seeded in 5 cell culture petri dishes and evaluated
NUMBER OF CELLS SEEDED: 4 x 10^5 cells per petri dish
DETERMINATION OF CYTOTOXICITY: relative survival (RS) - Evaluation criteria:
- A test chemical is considered to be clearly negative if, in all experimental conditions examined
- none of the test concentrations exhibits a statistically significant increase compared with the concurrent negative control,
- there is no concentration-related increase when evaluated with an appropriate trend-test
- all results are inside the distribution of the historical negative control data
A test chemical is considered to be clearly positive if, in any of the experimental conditions examined
- at least one of the test concentrations exhibits a statistically significant increase compared with the concurrent negative control, and
- the increase is concentration-related when evaluated with an appropriate trend test, and
- any of the results are outside the distribution of the historical negative control data.
- 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.
According to the OECD guideline, the biological relevance is considered first for the interpretation of results. - Statistics:
- The non-parametric Mann-Whitney test is applied to the mutation data to prove the dose groups for any significant difference in mutant frequency compared to the negative control. Additionally, a dose-response realationship was determined in the X² test for trend.
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
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
Any other information on results incl. tables
Precipitation
Precipitation of the test item was noted at concentrations of 0.25 mg/mL and higher without metabolic activation and with metabolic activation at concentrations of 0.2 mg/mL and higher.
Toxicity
A biologically relevant growth inhibition (reduction of relative survival below 70%) was observed after the treatment with the test item in experiment I with and without metabolic activation.
In experiment I, the relative survival was 66% (without metabolic activation) and 8% (with metabolic activation) for the highest tested concentration of 0.50 mg/mL.
Mutagenicity
In the experiment without and with metabolic activation all validity criteria were met. The mutant values of the negative controls fall within the historical data range of the test facility and the cloning efficiencies of the negative and solvent controls are > 50%.
The positive controls, DMBA (1.0 μg/mL) and EMS (300 μg/mL) showed statistically significant increases in mutant frequency, thereby demonstrating both the sensitivity and validity of the test systems.
In the experiment without metabolic activation the mutant values of the negative controls, the solvent controls and all mutant values of the test item concentrations found were within the historical control data of the test facility Eurofins Munich (about 7.8 - 39.7 mutants per 10E6 cells). The positive control EMS induced a distinct increase in mutant frequency with 240.5 mutants/10E6 cells.
The mutant frequencies of the negative controls were 21.5 and 20.1 mutants per 10E6 cells, of the solvent controls 30.4 and 15.6 mutants per 10E6 cells, respectively, and in the range of 9.9 to 31.4 mutants per 10E6 cells with the test item.
The highest mutant frequency was observed at a concentration of 0.25 mg/mL (31.4 mutants per 10E6 cells) with a relative survival of 42%.
The mutant frequencies induced by the test item did not show a biologically relevant increase. None of the observed mutant frequencies were statistically significantly increased over those of the solvent controls.
In the experiment with metabolic activation the mutant values of the negative controls, the solvent controls and all mutant values of the test item concentrations found were within or even lower than the historical control data of the test facility Eurofins Munich (about 9.2 – 38.8 mutants per 10E6 cells). The positive control DMBA induced a distinct increase in mutant frequency with 272.7 mutants/10E6 cells.
The mutant frequencies of the negative controls were 13.4 and 23.1 mutants per 10E6 cells, of the solvent controls 14.6 and 14.0 mutants per 10E6 cells, respectively, and in the range of 4.0 to 21.6 mutants per 10E6 cells with the test item, respectively.
The highest mutant frequency was observed at a concentration of 0.05 mg/mL (21.6 mutants per 10E6 cells) with a relative survival of 72%.
A statistical analysis displayed that one of the mutant frequencies was significantly increased over those of the solvent controls, but there was no evidence for a dose-response relationship. Therefore, this effect was considered as not biologically relevant.
Applicant's summary and conclusion
- Conclusions:
- In conclusion, in the described mutagenicity test under the experimental conditions reported, the test item Cyclohexene-1,2-dicarboxylic acid, methyl-, castor-oil alkyl esters is considered to be non-mutagenic at the HPRT locus using V79 cells of the Chinese Hamster.
- Executive summary:
The test item Cyclohexene-1,2-dicarboxylic acid, methyl-, castor-oil alkyl esters was assessed for its potential to induce mutations at the HPRT locus using V79 cells of the Chinese Hamster.
The selection of the concentrations was based on data from the pre-experiment. With and without metabolic activation were performed as a 4 h short-term exposure assay.
The test item was investigated at the following concentrations:
without metabolic activation: 0.05, 0.10, 0.15, 0.20 and 0.25 mg/mL
with metabolic activation: 0.01, 0.05, 0.10, 0.15, 0.20 and 0.25 mg/mL
Precipitation of the test item was noted at concentrations of 0.2 mg/mL (with metabolic activation) and 0.25 mg/mL (without metabolic activation).
Biologically relevant growth inhibition (relative survival < 70%) was observed in the experiment with and without metabolic activation. Without metabolic activation the relative survival was 66% and with metabolic activation 8% for the highest concentration (0.5 mg/mL).
In the experiments no biologically relevant increase of mutants was found after treatment with the test item without and with metabolic activation. All mutant values were within the historical data base of the test facility.
A statistical analysis displayed that one of the mutant frequencies was significantly increased over those of the solvent controls, but there was no evidence for a dose-response relationship.
DMBA and EMS were used as positive controls and showed distinct and biologically relevant effects in mutation frequency.
Conclusion
In conclusion, in the described mutagenicity test under the experimental conditions reported, the test item Cyclohexene-1,2-dicarboxylic acid, methyl-, castor-oil alkyl esters is considered to be non-mutagenic at the HPRT locus using V79 cells of the Chinese Hamster.
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