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EC number: 944-290-5 | CAS number: -
- 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:
- 2014-08-20 to 2014-10-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Version / remarks:
- (1997)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- Version / remarks:
- (2008)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5375 - In vitro Mammalian Chromosome Aberration Test
- Version / remarks:
- (1998)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Harlan Cytotest Cell Research GmbH (Harlan CCR), In den Leppsteinswiesen 19, 64380 Rossdorf, Germany
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Reaction product of Propanoic acid, 3-[[bis(2-methylpropoxy)phosphinothioyl]thio]-2-methyl- and tridecanamine, N-tridecyl-, branched and linear
- EC Number:
- 944-290-5
- Molecular formula:
- C38H80NO4PS2 (idealized)
- IUPAC Name:
- Reaction product of Propanoic acid, 3-[[bis(2-methylpropoxy)phosphinothioyl]thio]-2-methyl- and tridecanamine, N-tridecyl-, branched and linear
- Test material form:
- liquid: viscous
1
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- - Type and identity of media:
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: yes - Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix (Phenobarbital/β-naphthoflavone induced rat liver)
- Test concentrations with justification for top dose:
- Pre-experiment: 20.3, 40.6, 162.5, 325.0, 650.0, 1300.0, 2600.0 µg/mL, 5.2 µL/mL (with and without S9 mix)
Experiment I: 0.3, 0.7, 1.6, 4.1, 10.2, 25.6, 64.0, 160.0, 400.0 µg/mL (with and without S9 mix)
Experiment II: 0.1, 0.3, 0.7, 1.6, 4.1, 10.2, 25.6, 64.0, 160.0 µg/mL (18 and 28 hours without S9 mix)
Experiment II: 0.3, 0.7, 1.6, 4.1, 10.2, 25.6, 64.0, 160.0, 320.0 µg/mL (4 hours with S9 mix) - Vehicle / solvent:
- - Vehicle used: ethanol
- Justification for choice of solvent/vehicle: The solvent was chosen due to its solubility properties and its relative non-toxicity to the cell cultures.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- EMS
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- without S9 mix at concentrations of 1000.0 (Exp. I), 600.0 (Exp. II, 18 h treatment), 500.0 (Exp. II, 28 h treatment) µg/mL
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- CPA
- Positive control substance:
- cyclophosphamide
- Remarks:
- with S9 mix at concentrations of 1.4 (Exp. I) and 2.0 (Exp. II) µg/mL
- Details on test system and experimental conditions:
- RANGE FINDING EXPERIMENT
A preliminary cytotoxicity test was performed to determine the concentrations to be used in the main experiment. Cytotoxicity is characterized by the percentages of mitotic suppression and/or reduction in cell number in comparison to the controls by counting 1000 cells per culture in duplicate. The experimental conditions in this pre-test phase were identical to those required and described below for the main experiment.
The pre-test was performed with 9 concentrations of the test item separated by no more than a factor of √10 and a solvent and positive control. All cell cultures were set up in duplicate. Exposure time was 4 hrs (with and without S9 mix). The preparation interval was 18 hrs after start of the exposure.
MAIN EXPERIMENT
METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 4 hours ±S9 mix (Exp. I); 4 hours +S9 mix (Exp. II); 18 and 28 hours -S9 mix (Exp. II)
- Expression time (cells in growth medium): 14 and 24 hours, resp.
- Fixation time (start of exposure up to fixation or harvest of cells): 18 h (Exp. I and II) and 28 h (Exp. II)
SPINDLE INHIBITOR (cytogenetic assays): Colcemid
STAIN (for cytogenetic assays): Giemsa
NUMBER OF REPLICATIONS: 2
NUMBER OF CELLS EVALUATED: 100 well-spread metaphases
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index
OTHER EXAMINATIONS:
- Determination of polyploidy: Yes
- Determination of endoreplication: Yes - Evaluation criteria:
- The chromosomal aberration assay will be considered acceptable if it meets the following criteria:
a) The rate of chromosomal aberrations in the solvent controls falls within the historical laboratory control data range.
b) The rate of chromosomal aberrations in the positive controls is statistically significant increased.
A test item can be classified as non-clastogenic if:
− the number of induced structural chromosomal aberrations in all evaluated dose groups is in the range of the historical laboratory control data and
− no statistically significant increase of the rate of structural chromosomal aberrations is observed in comparison to the respective solvent control.
A test item can be classified as clastogenic if:
− the number of induced structural chromosomal aberrations is not in the range of the historical laboratory control data and
− either a concentration-related or a statistically significant increase in the number of cells carrying structural chromosomal aberrations is observed.
If the above mentioned criteria for the test item are not clearly met, the test item will be classified as equivocal or a confirmatory experiment may be performed. However, results may remain questionable regardless of the number of times the experiment is repeated.
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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: No relevant influence on pH was observed.
- Effects of osmolality: No relevant influence on osmolarity was observed.
- Precipitation: No visible precipitation of the test item in the culture medium was observed in this study. Phase separation was observed at 160.0 μg/mL and above in Experiment I in the absence and presence of S9 mix. In Experiment II phase separation was observed at 25.6 μg/mL and above in the absence of S9 mix after 28 hours continuous treatment and at 64.0 μg/mL and above in the presence of S9 mix.
RANGE-FINDING/SCREENING STUDIES:
With regard to the purity (97 %) of the test item, 5.2 μL/mL were applied as top concentration for treatment of the cultures in the pre-test. Test item concentrations ranging from 20.3 μg/mL to 5.2 μL/mL (with and without S9 mix) were chosen for the evaluation of cytotoxicity. In the pre-test for toxicity, no precipitation of the test item was observed. Since the cultures did not fulfill the requirements for cytogenetic evaluation, due to strong test item-induced toxic effects, this preliminary test was repeated with a top dose of 400.0 μg/mL (with and without S9 mix) and designated Experiment I. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Results
Experiment |
Exposure period [h] |
Dose (µg/mL) |
S9 mix |
Prec. |
Aberrant cells in % |
Mitotic indices in % of control |
|
1 |
4 |
Negative control |
- |
- |
1.0 |
100.0 |
|
|
|
Positive control |
- |
- |
8.5 |
121.5 |
|
|
|
0.7 |
- |
- |
1.0 |
114.6 |
|
|
|
1.6 |
- |
- |
0.0 |
92.7 |
|
|
|
4.1 |
- |
- |
1.5 |
46.3 |
|
|
|
|
|
|
|
|
|
2 |
18 |
Negative control |
- |
- |
1.0 |
100.0 |
|
|
|
Positive control |
- |
- |
19.5 |
95.6 |
|
|
|
0.3 |
- |
- |
2.0 |
125.7 |
|
|
|
0.7 |
- |
- |
1.5 |
108.0 |
|
|
|
1.6 |
- |
- |
0.5 |
76.5 |
|
|
|
|
|
|
|
|
|
2 |
28 |
Negative control |
- |
- |
2.0 |
100.0 |
|
|
|
Positive control |
- |
- |
39.0 |
32.7 |
|
|
|
0.1 |
- |
- |
1.0 |
118.1 |
|
|
|
0.3 |
- |
- |
1.5 |
99.4 |
|
|
|
0.7 |
- |
- |
1.0 |
56.7 |
|
|
|
|
|
|
|
|
|
1 |
4 |
Negative control |
+ |
- |
1.5 |
100.0 |
|
|
|
Postive control |
+ |
- |
15.5 |
64.1 |
|
|
|
10.2 |
+ |
- |
2.5 |
97.7 |
|
|
|
25.6 |
+ |
- |
1.0 |
117.0 |
|
|
|
64 |
+ |
- |
1.0 |
61.0 |
|
|
|
|
|
|
|
|
|
2 |
4 |
Negative control |
+ |
- |
1.0 |
100.0 |
|
|
|
Positive control |
+ |
- |
18.5 |
85.3 |
|
|
|
4.1 |
+ |
- |
3.5 |
95.8 |
|
|
|
10.2 |
+ |
- |
2.0 |
85.3 |
|
|
|
25.6 |
+ |
- |
1.0 |
99.0 |
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.