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EC number: 287-619-1 | CAS number: 85563-48-0
- 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 bacteria
- 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: Well performed guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Hexadecyl(2-hydroxyethyl)dimethylammonium dihydrogen phosphate
- EC Number:
- 287-619-1
- EC Name:
- Hexadecyl(2-hydroxyethyl)dimethylammonium dihydrogen phosphate
- Cas Number:
- 85563-48-0
- Molecular formula:
- C20H44NO.H2O4P
- IUPAC Name:
- dihydrogen hexadecyl(2-hydroxyethyl)dimethylazanium phosphate
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Product name, 00/0259-4
- Physical state: liquid, yellowish, clear
- Expiration date of the lot/batch: 22 Aug 2016
- Stability under test conditions: The stability of the test substance under storage conditions is guaranteed until 22 Aug 2016
- Storage condition of test material: room temperature
Constituent 1
Method
- Target gene:
- histidine gene
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 fraction
- Test concentrations with justification for top dose:
- SPT: 0, 33, 100, 333, 1000, 2500, 5000 µg/L
PIT: 0, 1, 3.3, 10, 33, 100, 333 µg/L - Vehicle / solvent:
- water
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- other: 2-aminoanthracene, N-methyl-N'-nitro-N-nitrosoguanidine, 4-nitro-o-phenylenediamine
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: 20 minutes
- Exposure duration: 48 - 72h - Evaluation criteria:
- Generally, the experiment was considered valid if the following criteria were met:
• The number of revertant colonies in the negative controls was within the range of the historical negative control data for each tester strain.
• The sterility controls revealed no indication of bacterial contamination.
• The positive control substances both with and without S9 mix induced a distinct increase in the number of revertant colonies within the range of the historical positive control data or above.
• Fresh bacterial culture containing approximately 109 cells per mL were used.
The test substance was considered positive in this assay if the following criteria were met:
• A dose-related and reproducible increase in the number of revertant colonies, i.e. at least doubling (bacteria strains with high spontaneous mutation rate, like TA 98, TA 100 and E.coli WP2 uvrA) or tripling (bacteria strains with low spontaneous mutation rate, like TA 1535 and TA 1537) of the spontaneous mutation rate in at least one tester strain either without S9 mix or after adding a metabolizing system.
A test substance was generally considered non-mutagenic in this test if:
• The number of revertants for all tester strains were within the historical negative control data range under all experimental conditions in at least two experiments carried out independently of each other. - Statistics:
- Arithmetic mean and standard deviation of back-mutant colonies per plate
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- A strong bacteriotoxic effect was observed depending on the strain and test conditions from about 100 μg/plate onward
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Precipitation of the test substance was found depending on the
test conditions from about 100 μg/plate onward. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
SPT without metabolic activation (1st Run):
|
Mean revertants per plate |
||||
|
TA 1535 |
TA 100 |
TA 1537 |
TA 98 |
E. coli |
Control |
8.3 |
97.7 |
9.0 |
14.0 |
28.0 |
33 µg/plate |
11.7 |
101.0 |
6.7 |
17.7 |
21.3 |
100 µg/plate |
10.0 |
64.0 |
6.7 |
21.7 |
19.7 |
333 µg/plate |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
1000 µg/palte |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
2500 µg/plate |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
5000 µg/plate |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
Positive control |
4472.7 |
3568.3 |
645.7 |
461.7 |
1265.3 |
SPT with metabolic activation:
|
Mean revertants per plate |
||||
|
TA 1535 |
TA 100 |
TA 1537 |
TA 98 |
E. coli |
Control |
7.7 |
94.0 |
8.0 |
22.0 |
24.3 |
33 µg/plate |
8.3 |
102.7 |
8.7 |
24.3 |
21.3 |
100 µg/plate |
11.0 |
8.3 |
8.3 |
13.3 |
22.0 |
333 µg/plate |
8.7 |
7.3 |
2.7 |
4.0 |
13.0 |
1000 µg/palte |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
2500 µg/plate |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
5000 µg/plate |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
Positive control |
284.0 |
2360.3 |
213.7 |
2427.3 |
149.0 |
SPT without metabolic activation (2nd Run):
|
Mean revertants per plate |
||||
|
TA 1535 |
TA 100 |
TA 1537 |
TA 98 |
E. coli |
Control |
12.3 |
97.7 |
11.0 |
20.0 |
31.3 |
1.0 µg/plate |
13.7 |
101.0 |
11.3 |
20.0 |
30.0 |
3.3 µg/plate |
9.3 |
92.7 |
9.7 |
18.3 |
29.0 |
10 µg/plate |
13.0 |
109.0 |
12.0 |
21.0 |
29.0 |
33 µg/palte |
12.7 |
97.0 |
8.0 |
21.0 |
22.3 |
100 µg/plate |
13.7 |
68.3 |
8.7 |
9.0 |
15.3 |
333 µg/plate |
3.0 |
0.0 |
0.0 |
0.0 |
0.0 |
Positive control |
4570.3 |
3632.7 |
897.7 |
440.3 |
1281.3 |
SPT with metabolic activation (2nd Run):
|
Mean revertants per plate |
||||
|
TA 1535 |
TA 100 |
TA 1537 |
TA 98 |
E. coli |
Control |
9.7 |
97.7 |
14.3 |
23.3 |
28.0 |
1.0 µg/plate |
10.0 |
97.7 |
10.7 |
25.7 |
34.4 |
3.3 µg/plate |
12.0 |
84.0 |
10.7 |
24.7 |
21.0 |
10 µg/plate |
11.0 |
95.0 |
11.0 |
24.3 |
30.3 |
33 µg/palte |
11.3 |
109.0 |
12.7 |
24.7 |
29.3 |
100 µg/plate |
12.0 |
99.0 |
12.7 |
23.7 |
24.0 |
333 µg/plate |
6.3 |
7.7 |
5.0 |
9.0 |
7.7 |
Positive control |
256.3 |
1840.0 |
192.7 |
1980.7 |
166.7 |
PIT without metabolic activation (1st Run):
|
Mean revertants per plate |
||||
|
TA 1535 |
TA 100 |
TA 1537 |
TA 98 |
E. coli |
Control |
9.0 |
100.7 |
6.3 |
18.0 |
22.3 |
1.0 µg/plate |
8.0 |
84.3 |
7.0 |
13.3 |
27.0 |
3.3 µg/plate |
8.3 |
98.3 |
5.3 |
18.0 |
19.3 |
10 µg/plate |
10.7 |
101.0 |
8.3 |
18.7 |
17.7 |
33 µg/palte |
9.3 |
86.7 |
7.0 |
13.0 |
24.0 |
100 µg/plate |
3.7 |
33.7 |
3.7 |
6.0 |
26.0 |
333 µg/plate |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
Positive control |
2553.0 |
1885.0 |
498.7 |
473.3 |
297.3 |
PIT with metabolic activation (1st Run):
|
Mean revertants per plate |
||||
|
TA 1535 |
TA 100 |
TA 1537 |
TA 98 |
E. coli |
Control |
10.7 |
98.0 |
6.0 |
23.7 |
21.3 |
1.0 µg/plate |
10.3 |
127.3 |
8.0 |
26.0 |
23.7 |
3.3 µg/plate |
10.0 |
121.7 |
9.3 |
24.3 |
25.0 |
10 µg/plate |
10.3 |
105.7 |
9.7 |
29.0 |
25.3 |
33 µg/palte |
8.3 |
113.7 |
6.0 |
20.0 |
22.7 |
100 µg/plate |
10.3 |
110:7 |
5.7 |
30.0 |
20.7 |
333 µg/plate |
6.0 |
9.7 |
0.0 |
0.0 |
0.0 |
Positive control |
234.0 |
1880.7 |
139.0 |
1391.0 |
90.0 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Under the experimental conditions of this study, the test substance was not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay in the absence and the presence of metabolic activation. - Executive summary:
The test substance was tested for its mutagenic potential based on the ability to induce point mutations in selected loci of several bacterial strains (TA 1535, TA 100, TA 1537, TA 98, E.coli WP2 uvrA) in a reverse mutation assay. The mutagenic potential was tested in a dose range of 1.0 o 5000 µg/plate in the SPT and in a range of 1.0 to 333 µg/plate in the PIT. The PIT and the SPT were both performed with and without metabolic activation (liver S9 mix from induced rats). Precipitation of the test substance was found depending on the strain and test conditions from about 100 µg/plate onward. A strong bacteriotoxic effect was observed depending on the strain and test conditions from about 100 µg/plate onward. A relevant increase in the number of his+ or trp+ revertants was not observed in the standard plate test or in the preincubation test either without S9 mix or after the addition of a metabolizing system.
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