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EC number: 939-498-8 | 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 gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Version / remarks:
- adopted July 21, 1997
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- Reaction product of fatty acids C14-18/C16-18 unsaturated with dihydrogendioxide and Ammonia
- Molecular formula:
- Reaction product of fatty acids C14-18/C16-18 unsaturated with dihydrogendioxide and Ammonia
- IUPAC Name:
- Reaction product of fatty acids C14-18/C16-18 unsaturated with dihydrogendioxide and Ammonia
- Details on test material:
- - Name of test material (as cited in study report): DHW 80
- Molecular weight: approximately 333 g/mol
- Physical state: liquid at room temperature
- Colour: brown
- Analytical purity: approximately 49 - 51 % (water content 50 %)
- Lot/batch No.: 10393
- Expiration date of the lot/batch: 1994-11-04
- Stability: pure - months; in solvent - in water stable for several hours, unstable in alkaline solutions
- Storage condition of test material: at room temperature
Constituent 1
Method
- Target gene:
- HPRT locus
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Mininmal Essential Medium (MEM), SEROMED, D-12247 Berlin, supplemented with 10 % fetal calf serum
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: yes
- Periodically "cleansed" against high spontaneous background: no
- Metabolic activation:
- with and without
- Metabolic activation system:
- co-factor supplemented post-mitochondrial fractions (S9 mix), prepared from livers of 8-12 weeks old male rats treated with Aroclor 1254 in olive oil 5 days before
- Test concentrations with justification for top dose:
- Experiment I:
without S9 mix: 3.0*, 6.0, 10.0, 30.0, 60.0, 100.0** µg/mL
with S9 mix: 16.5, 60.0, 100.0, 15.0 µg/mL
Experiment II:
without S9 mix: 6.0, 10.0, 30.0, 40.0, 50.0**, 60.0** µg/mL
with S9 mix: 16.5, 60.0, 100.0, 165.0 µg/mL
*not evaluated, culture not continued; ** not evaluable, toxic effects - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO (E. MERCK, D-64293 Darmstadt, purity > 99.5%)
- Justification for choice of solvent/vehicle: chosen according to its solubility properties and its non-toxicity for the cell culture system, final concentration in cell culture medium did not exceed 1% (v/v)
Controls
- Untreated negative controls:
- yes
- Remarks:
- untreated cells
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: EMS (Ethylmethanesulfonate) - 0.6 mg/mL = 4.8 mM dissolved in nutrient medium (MEM without FCS), without metabolic activation; DMBA (7,12-dimethylbenz(a)anthracene - 3.85 µg/mL = 15.0 mM dissolved in DMSO, with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in serumfree medium
DURATION
- Exposure duration: 4 hours
- Expression time (cells in growth medium): Cells were treated for 4 hours on day 2. After incubation cells were washed and incubated with fresh complete growth medium. On day 5 cells of experiments without S9 mix were subcultivated in 175 cm² flasks, cells out of experiments with S9 mix were subcultivated on day 6. Selection with TG6 medium was carried out from day 9 to day 17.
- Selection time (if incubation with a selection agent): 8 days
- Fixation time (start of exposure up to fixation or harvest of cells): fixation was carried out on one day
SELECTION AGENT (mutation assays): Thioguanine - 11 µg/mL (SIGMA gmbH, D-82041 Deisenhofen)
NUMBER OF REPLICATIONS: duplicates each in 2 independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth - Evaluation criteria:
- Test substance is classified "positive" if it induces either a concentration-related increase of the mutant frequency or a reproducible and positive response for one of the test points.
Test substance is classified "mutagenic" if it induces reproducibly a mutant frequency that is three times higher then the spontaneous mutation frequency in the experiment or if there is a reproducible concentration-related increase of the mutation frequency. - Statistics:
- Since the distribution of mutant cells does not follow known statistical models, an adequate statistical method is not available.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- concentration-dependent toxicity was observed, which was less pronounced in experiment I compared to experiment II
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES:
Without S9 mix test substance reduced the cloning efficiency of V79 cells at concentrations higher than 30.0 µg/mL. With S9 mix no toxicity could be observed up to the limit of solubility of the test substance. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table1: Experiment I: without metabolic activation
Concentration [µg/mL] |
Cloning Efficiency [%] |
Relative Total Growth [%] |
Mutants per 1E+06 Surviving Cells |
Mutation Factor |
Negative control |
100 |
100 |
7.8 |
1.0 |
Solvent control (DMSO) |
100 |
100 |
9.2 |
1.2 |
Positive control (EMS) |
52.3 |
88.9 |
394 |
50.5 |
6.0 |
111.5 |
107.8 |
11.5 |
1.5 |
10.0 |
92.1 |
114.6 |
13.8 |
1.8 |
30.0 |
63.9 |
97.6 |
6.9 |
0.9 |
60.0 |
2.6 |
79.1 |
10.8 |
13.9 |
Table2: Experiment I: with metabolic activation
Concentration [µg/mL] |
Cloning Efficiency [%] |
Relative Total Growth [%] |
Mutants per 1E+06 Surviving Cells |
Mutation Factor |
Negative control |
100 |
100 |
1.6 |
1.0 |
Solvent control (DMSO) |
100 |
100 |
13.6 |
8.5 |
Positive control (DMBA) |
55.1 |
75.3 |
451.9 |
282.4 |
16.5 |
136.3 |
101.9 |
4.2 |
2.6 |
60.0 |
136.5 |
102.3 |
4.3 |
2.7 |
100.0 |
45.3 |
75.9 |
2.1 |
1.3 |
165.0 |
20.2 |
95.4 |
8.6 |
5.4 |
Table3: Experiment II: without metabolic activation
Concentration [µg/mL] |
Cloning Efficiency [%] |
Relative Total Growth [%] |
Mutants per 1E+06 Surviving Cells |
Mutation Factor |
Negative control |
100 |
100 |
17.1 |
1.0 |
Solvent control (DMSO) |
100 |
100 |
7.2 |
0.4 |
Positive control (EMS) |
82.8 |
87.6 |
448 |
26.2 |
6.0 |
91.1 |
92.4 |
19.1 |
1.1 |
10.0 |
72.5 |
106.7 |
6.4 |
0.4 |
30.0 |
0.5 |
85.9 |
17.5 |
1.0 |
40.0 |
0.3 |
45.4 |
16.4 |
1.0 |
Table4: Experiment II: with metabolic activation
Concentration [µg/mL] |
Cloning Efficiency [%] |
Relative Total Growth [%] |
Mutants per 1E+06 Surviving Cells |
Mutation Factor |
Negative control |
100 |
100 |
24.5 |
1.00 |
Solvent control (DMSO) |
100 |
100 |
0.0
|
0.0 |
Positive control (DMBA) |
61.9 |
109.8 |
466.3 |
19.0 |
16.5 |
103.5 |
117.1 |
17.5 |
0.7 |
60.0 |
94.6 |
104.6 |
17.6 |
0.7 |
100.0 |
98.2 |
96.6 |
16.1 |
0.7 |
165.0 |
93.1 |
90.2 |
10.8 |
0.4 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported the test article did not induce gene mutations at the HPRT locus in V79 cells. Therefore, DHW 80 is considered to be non-mutagenic in this HPRT assay.
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