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EC number: 268-582-0 | CAS number: 68130-25-6
- 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 cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 Feb 2017 - 01 jun 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian cell transformation assay
Test material
- Reference substance name:
- Decanoic acid, ester with 2,2-bis(hydroxymethyl)-1,3-propanediol 2-ethylhexanoate octanoate
- EC Number:
- 268-582-0
- EC Name:
- Decanoic acid, ester with 2,2-bis(hydroxymethyl)-1,3-propanediol 2-ethylhexanoate octanoate
- Cas Number:
- 68130-25-6
- Molecular formula:
- C10 H20 O2 . x C8 H16 O2 . x C8 H16 O2 . x C5 H12 O4
- IUPAC Name:
- Decanoic acid, ester with 2,2-bis(hydroxymethyl)-1,3-propanediol 2-ethylhexanoate octanoate
- Test material form:
- liquid
- Details on test material:
- Identification: H-32
CAS No.: 68130-25-6
Batch: 64296
Purity: > 99%
Appearance: Pale yellow liquid
Expiry Date: 30 September 2018
Storage Conditions: At room temperature
Stability in Solvent: Not relevant
Purpose of Use: Industrial chemical
Constituent 1
- Specific details on test material used for the study:
- - Identification: H-32
- CAS Number: 68130-25-6
- Sponsors Description: Pale yellow liquid
- Batch: 64296
- Purity: > 99%
- Molecular Weight: Theoretical value 704.6
Measured value 706.0
- Expiry Date: 30 September 2018
- Storage Conditions: Room temperature in the dark
Method
Species / strain
- Species / strain / cell type:
- lymphocytes:
- Details on mammalian cell type (if applicable):
- CELLS USED
- Source of cells:human lymphocytes
- Sex, age and number of blood donors if applicable:
Preliminary Toxicity Test: female, aged 33 years
Main Experiment: male, aged 29 years
MEDIA USED
- CO2 concentration if applicable: 5% - Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver homogenate metabolizing system (S9)
- Test concentrations with justification for top dose:
- i) 4-hour exposure without S9-mix - the dose range of test item used was 0, 2, 4, 8, 16, 32, 64, 128μg/mL.
ii) 4-hour exposure with S9-mix (2%) - the dose range of test item used was 0, 4, 8, 16, 32, 64, 128 and 256 μg/mL.
iii) 24-hour continuous exposure to the test item without S9-mix - the dose range of test item used was 0, 2, 4, 8, 16, 32, 64 and 128 μg/mL. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: acetone
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- mitomycin C
- Remarks:
- Mitomycin C used in abcence of S9-mix. Cyclophosphamide (CP) used in the presance of S9-mix
- Details on test system and experimental conditions:
- DURATION
- Exposure duration: 4 and 24 hours at approx 37 ºC, 5% CO2 in humidified air
NUMBER OF REPLICATIONS: duplicates
METHODS OF SLIDE PREPARATION AND STAINING TECHNIQUE USED: dry slides were stained in 5% Giemsa for 5 minutes, rinsed, dried and a cover slip applied using mounting medium
NUMBER OF CELLS EVALUATED: 2000 - Evaluation criteria:
- Providing that all of the acceptability criteria are fulfilled, a test item can be considered to be clearly negative if, in any of the experimental conditions examined:
1) The number of cells with structural aberrations in all evaluated dose groups should be within the range of the laboratory historical control data.
2) No toxicologically or statistically significant increase of the number of cells with structural chromosome aberrations is observed following statistical analysis.
3) There is no concentration-related increase at any dose level
A test item can be classified as genotoxic if:
1) The number of cells with structural chromosome aberrations is outside the range of the laboratory historical control data.
2) At least one concentration exhibits a statistically significant increase in the number of cells with structural chromosome aberrations compared to the concurrent negative control.
3) The observed increase in the frequency of cells with structural aberrations is considered to be dose-related
When all of the above criteria are met, the test item can be considered able to induce chromosomal aberrations in human lymphocytes.
Although the inclusion of the structural chromosome aberrations is the purpose of this study, it is important to include numerical aberrations in the form of polyploidy and endoreduplicated cells. - Statistics:
- The frequency of cells with aberrations excluding gaps and the frequency of polyploid cells was compared, where necessary, with the concurrent vehicle control value using Fisher's Exact test. (Richardson et al. 1989).
A toxicologically significant response is recorded when the p value calculated from the statistical analysis of the frequency of cells with aberrations excluding gaps is less than 0.05 when compared to its concurrent control and there is a dose-related increase in the frequency of cells with aberrations which is reproducible. Incidences where marked statistically significant increases are observed only with gap-type aberrations will be assessed on a case by case basis.
Results and discussion
Test results
- Key result
- Species / strain:
- other: Human lymphocytes
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
Any other information on results incl. tables
Dose level (µg/mL) | 24 Hour without S9 | |
Mean | % Control Group | |
0 | 5.65 | 100 |
2 | - | - |
4 | - | - |
8 | 7.50 | 133 |
16 | 8.33 | 147 |
32 | 8.65 | 153 |
64 | - | - |
128 | - | - |
MMC 0.1 | 2.9 | 51 |
Applicant's summary and conclusion
- Conclusions:
- The test item was non-toxic and did not induce any statistically significant increases in the frequency of cells with aberrations, using a dose range that included a dose level that was the lowest precipitating dose level.
The test item,was considered to be non-clastogenic to human lymphocytes in vitro. - Executive summary:
Introduction
This report describes the results of an in vitro study for the detection of structural chromosomal aberrations in cultured mammalian cells. It supplements microbial systems insofar as it identifies potential mutagens that produce chromosomal aberrations rather than gene mutations (Scott et al., 1991).
Methods
Duplicate cultures of human lymphocytes, treated with the test item, were evaluated for chromosome aberrations at three dose levels, together with vehicle and positive controls. In this study, three exposure conditions were investigated; 4 hours exposure in the presence of an induced rat liver homogenate metabolizing system (S9), at a 2% final concentration with cell harvest after a 20-hour expression period, 4 hours exposure in the absence of metabolic activation (S9) with a 20-hour expression period and a 24-hour exposure in the absence of metabolic activation.
The dose levels used in the Main Experiment were selected using data from the preliminary toxicity test where the results indicated that the maximum concentration should be limited on precipitate. The dose levels selected for the Main Test were as follows:
Group Final concentration of test item H-32 (μg/mL) 4(20)-hour without S9 0, 2, 4, 8, 16, 32, 64, 128 4(20)-hour with S9 (2%) 0, 4, 8, 16, 32, 64, 128, 256 24-hour without S9 0, 2, 4, 8, 16, 32, 64, 128 Results
All vehicle (acetone) controls had frequencies of cells with aberrations within the range expected for normal human lymphocytes.
All the positive control items induced statistically significant increases in the frequency of cells with aberrations. Thus, the sensitivity of the assay and the efficacy of the S9-mix were validated.
The test item was non-toxic and did not induce any statistically significant increases in the frequency of cells with aberrations, using a dose range that included a dose level that was the lowest precipitating dose level.
Conclusion
The test item, H-32 was considered to be non-clastogenic to human lymphocytes in vitro.
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