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EC number: 204-614-1 | CAS number: 123-28-4
- 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
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992-08-05, 1992-11-11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, performed under GLP (exposure period of 2 hours)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- yes
- Remarks:
- (exposure period of 2 hours)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- Version / remarks:
- 1984
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Didodecyl 3,3'-thiodipropionate
- EC Number:
- 204-614-1
- EC Name:
- Didodecyl 3,3'-thiodipropionate
- Cas Number:
- 123-28-4
- Molecular formula:
- C30H58O4S
- IUPAC Name:
- didodecyl 3,3'-sulfanediyldipropanoate
- Details on test material:
- - Name of test material (as cited in study report): Dilauryl thiodipropionate
- Physical state: solid, white powder
- Analytical purity: 96.1 %
- Purity test date: 1992-06-01, 1992-06-11
- Lot/batch No.: Reagens 05/92
- Storage condition of test material: room temperature in the dark
Constituent 1
Method
- Target gene:
- not applicable
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: McCoy's 5A medium, 10% (v/v) foetal calf serum (FCS), and 100 µg/mL gentamycin
- Properly maintained: yes
- 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:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with Aroclor 1254
- Test concentrations with justification for top dose:
- 29.4, 42, and 60 µg/mL (experiment I) and 60, 92.3, and 142 µg/mL (experiment II)
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: acetone
- Justification for choice of solvent/vehicle: solubility
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- with metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- without metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 2 h (with metabolic activation, cells were then washed twice with sterile saline and re-fed with fresh medium containing foetal calf serum and gentamycin, cultures were then incubated for a further 18 or 42 hours before harvesting), 20 and 44 hours (without metabolic activation)
- Expression time (cells in growth medium): 18 and 42 hours (with S9-mix), 20 and 44 hours (without S9-mix)
- Fixation time (start of exposure up to fixation or harvest of cells): 20 and 44 hours
SPINDLE INHIBITOR (cytogenetic assays): colchicine (one and a half hours prior to harvest, colchicine was added to give a final concentration of approximately 1 µg/mL to arrest dividing cells in metaphase)
STAIN (for cytogenetic assays): Giemsa
NUMBER OF REPLICATIONS: 2 (4, only for the negative control)
NUMBER OF CELLS EVALUATED: 100 metaphases of each culture
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index
OTHER EXAMINATIONS:
- Determination of polyploidy: yes
- Determination of endoreplication: yes
- Determination of hyperdiploid cells: yes - Evaluation criteria:
- The CHO assay was to be considered valid if the following criteria were met:
1) the binomial dispersion test demonstrated acceptable heterogeneity between replicate cultures.
2) the proportion of cells with structural aberrations (excluding gaps) in negative control cultures fell within the normal range and the percentage of polyploid/ endoreduplicated/ hyperdiploid cells was <10%
3) at least 160 cells out of an intended 200 were analysable at each treatment level.
4) the positive control chemicals induced statistically significant increases in the number of cells with structural aberrations.
The test chemical was to be considered as clearly positive in this assay if:
1) statistically significant increases in the proportion of cells with structural aberrations (excluding gaps) occurred at one or more concentration
2) the proportion of aberrant cells at such data points exceeded the normal range.
3) the results were confirmed in the second experiment.
Increases in numbers of cells with gaps or increases in the proportions of cells with structural aberrations not exceeding the normal range or occurring only at very high or very toxic concentrations were likely to be concluded as "equivocal". Cells with exchange aberrations or cells with greater than one aberration were to be considered of particular biological significance. A positive result only at the delayed harvest in Experiment II was to be taken as evidence of clastogenicity provided criteria 1 and 2 were met. - Statistics:
- Aberrant cells in each culture were categorized as follows:
1. cells with structural aberrations including gaps
2. cells with structural aberrations excluding gaps
3. polyploid, endoreduplicated or hyperdiploid cells.
The totals for category 2 in negative control cultures was used to determine whether the assay was acceptable or not.
The proportions of aberrant cells in each replicate were used to establish acceptable heterogeneity between replicates by means of a binomial dispersion test.
The proportion of cells in category 2 for each test treatment condition, were compared with the proportion in negative controls using Fisher's exact test. Probability values of p ≤ 0.05 were accepted as significant. The proportions of cells in categories 1 and 3 were examined in relation to historical control (normal) ranges.
Results and discussion
Test results
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: low
- Precipitation: at 39 µg/mL and above
COMPARISON WITH HISTORICAL CONTROL DATA: Comparable. Few values (mostly positive controls, one test substance, and two solvent controls) exceeded historical negative control ranges. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table: Chromosomal aberrations in CHO cells after treatment with the test substance:
Experiment I |
||||
Test item |
Concentration |
Mitotic Index |
Cells with aberrations |
|
|
in µg/mL |
mean |
including gaps |
excluding gaps |
Exposure period 2h, fixation time 18h, with S9 mix |
||||
Solvent |
0 |
10.6 |
8 |
5 |
CPA |
12.5 |
- |
24 |
21 |
Test substance |
29.4 |
14.5 |
6 |
6 |
42 |
11.9 |
7 |
5 |
|
60 |
12.8 |
4 |
3 |
|
Exposure period 20h, without S9 mix |
||||
Solvent |
0 |
5 |
4 |
2 |
NQO |
0.0625 |
- |
24 |
23 |
Test substance |
29.4 |
3.9 |
8 |
4 |
42 |
5.1 |
8 |
4 |
|
60 |
3.7 |
4 |
2 |
|
Experiment II |
||||
Exposure period 2h, fixation time 18h, with S9 mix |
||||
Solvent |
0 |
7.3 |
2 |
2 |
CPA |
25 |
- |
47 |
46 |
Test substance |
60 |
6.3 |
4 |
2 |
92.3 |
7.3 |
6 |
4 |
|
142 |
6.5 |
7 |
5 |
|
Exposure period 20h, without S9 mix |
||||
Solvent |
0 |
4.6 |
5 |
1 |
NQO |
0.125 |
- |
22 |
22 |
Test substance |
60 |
4.3 |
6 |
3 |
92.3 |
2.6 |
5 |
3 |
|
142 |
3 |
4 |
1 |
|
Exposure period 2h, fixation time 42h, with S9 mix |
||||
Solvent |
0 |
1.8 |
11 |
6 |
Test substance |
92.3 |
1.1 |
9 |
7 |
Exposure period 44h, without S9 mix |
||||
Solvent |
0 |
5.2 |
8 |
2 |
Test substance |
142 |
7.8 |
7 |
2 |
CPA: cyclophosphamide
NQO: 4-nitroquinoline-N-oxide
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with and without metabolic activation
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