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EC number: 266-840-7 | CAS number: 67656-24-0
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 5 Oct 2017 - 7 Dec 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 21 July 1997
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Országos Gyógyszerészeti és Élelmezés-egészégügyi Intézet
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Sodium 2-butoxyethyl sulphate
- EC Number:
- 266-840-7
- EC Name:
- Sodium 2-butoxyethyl sulphate
- Cas Number:
- 67656-24-0
- Molecular formula:
- C6H14O5S.Na
- IUPAC Name:
- sodium 2-butoxyethyl sulphate
- Test material form:
- solid
Constituent 1
Method
- Target gene:
- his, trp operon
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- CELLS USED
- Source of cells: Trinova Biochem GmbH, Rathenau Str. 2, D-35394 Giessen, Germany
- Methods for maintenance in cell culture if applicable: The viability of each testing culture was determined by plating 0.1 mL of the 10E05, 10E06, 10E07 and 10E08 dilutions of cultures on nutrient agar plates.
MEDIA USED
- Type and identity of media including CO2 concentration if applicable: ready-to-use minimal glucose agar (MGA) plates
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: not reported
- Periodically checked for karyotype stability: not reported
- Periodically 'cleansed' against high spontaneous background: not reported - Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- E. coli WP2 uvr A
- Details on mammalian cell type (if applicable):
- CELLS USED
- Source of cells:
Trinova Biochem GmbH, Rathenau Str. 2, D-35394 Giessen, Germany
- Methods for maintenance in cell culture if applicable:
The viability of each testing culture was determined by plating 0.1 mL of the 10E05, 10E06, 10E07 and 10E08 dilutions of cultures on nutrient agar plates.
MEDIA USED
- Type and identity of media including CO2 concentration if applicable:
ready-to-use minimal glucose agar (MGA) plates
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: not reported
- Periodically checked for karyotype stability: not reported
- Periodically 'cleansed' against high spontaneous background: not reported - Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- post mitochondrial supernatant (S9) prepared from livers of Phenobarbital/β-naphthoflavone-induced rats
- Test concentrations with justification for top dose:
- 5000, 1600, 500, 160, 50 or 16 μg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ultrapure water (ASTM Type 1) and dimethyl sulfoxide (DMSO)
- Justification for choice of solvent/vehicle: In the preliminary Solubility and Concentration Range Finding Tests ultrapure water (ASTM Type 1) was found as appropriate vehicle for preparing the test item solutions. This vehicle is compatible with the survival of the bacteria and the S9 activity. DMSO also was used depending on the solubility of the test item and the solubility of positive control reference items.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-acetylaminofluorene
- 9-aminoacridine
- sodium azide
- methylmethanesulfonate
- other: 4-Nitro-1,2-phenylenediamine, NPD, 4 μg/plate, -S9, TA98
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: plate incorporation test for the initial mutation test and a pre-incubation test for the confirmatory mutation test
DURATION
- Preincubation period: 11-13 h
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: Conditions were investigated in triplicate.
DETERMINATION OF CYTOTOXICITY
- Method: colony and background lawn development - Evaluation criteria:
- A test item is considered mutagenic if:
- a dose–related increase in the number of revertants occurs and/or;
- a reproducible biologically relevant positive response for at least one of the dose groups occurs in at least one strain with or without metabolic activation.
An increase is considered biologically relevant if:
- in strain Salmonella typhimurium TA100 the number of reversions is at least twice as high as the reversion rate of the vehicle control,
- in strain Salmonella typhimurium TA98, TA1535, TA1537 and Escherichia coli WP2 uvrA the number of reversions is at least three times higher than the reversion rate of the vehicle control.
A test item is considered non-mutagenic if it produces neither a dose-related increase in the number of revertants nor a reproducible biologically.
The tests (Initial and Confirmatory Mutation Tests) are considered valid if:
- All of the Salmonella tester strains demonstrate the presence of the deep rough mutation (rfa) and the deletion in the uvrB gene.
- The Salmonella typhimurium TA98 and TA100 tester strains demonstrate the presence of the pKM101 plasmid R-factor.
- The Escherichia coli WP2 uvrA culture demonstrate the deletion in the uvrA gene.
- The bacterial cultures demonstrate the characteristic mean number of spontaneous revertants in the vehicle controls.
- The tester strain culture titers are in the 109 cells/mL order.
- The batch of S9 used in this study shows the appropriate biological activity.
- The reference mutagens show the expected increase (at least a 3.0-fold increase) in induced revertant colonies over the mean value of the respective vehicle control.
- There are at least five analyzable concentrations (at each tester strain) (a minimum of three non-toxic dose levels is required to evaluate assay data). - Statistics:
- Not performed.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- 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
- Key result
- Species / strain:
- S. typhimurium TA 1537
- 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
- Key result
- Species / strain:
- S. typhimurium TA 98
- 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
- Key result
- Species / strain:
- S. typhimurium TA 100
- 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
- Key result
- Species / strain:
- E. coli WP2 uvr A
- 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
Table 1: Summary of the Initial Mutation Test
Concentrations (µg/plate) |
Salmonella typhimurium tester strains |
Escherichia coli |
||||||||||||||||||
TA98 |
TA100 |
TA1535 |
TA1537 |
WP2uvrA |
||||||||||||||||
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|||||||||||
Mean values of revertants per plate and mutation rate(MR) |
Mean |
MR |
Mean |
MR |
Mean |
MR |
Mean |
MR |
Mean |
MR |
Mean |
MR |
Mean |
MR |
Mean |
MR |
Mean |
MR |
Mean |
MR |
UntreatedControl |
26.3 |
0.99 |
30.0 |
1.23 |
99.3 |
1.07 |
105.3 |
0.90 |
13.7 |
1.11 |
11.3 |
0.97 |
9.7 |
0.97 |
11.3 |
1.06 |
47.0 |
1.09 |
54.7 |
1.12 |
DMSOControl |
23.7 |
1.00 |
21.0 |
1.00 |
– |
– |
94.0 |
1.00 |
– |
– |
9.0 |
1.00 |
6.3 |
1.00 |
11.3 |
1.00 |
– |
– |
48.3 |
1.00 |
UltrapureWaterControl |
26.7 |
1.00 |
24.3 |
1.00 |
92.7 |
1.00 |
117.3 |
1.00 |
12.3 |
1.00 |
11.7 |
1.00 |
10.0 |
1.00 |
10.7 |
1.00 |
43.0 |
1.00 |
49.0 |
1.00 |
5000 |
30.3 |
1.14 |
29.0 |
1.19 |
89.0 |
0.96 |
106.3 |
0.91 |
11.7 |
0.95 |
10.3 |
0.89 |
8.0 |
0.80 |
11.0 |
1.03 |
53.0 |
1.23 |
56.7 |
1.16 |
1600 |
29.0 |
1.09 |
27.0 |
1.11 |
93.0 |
1.00 |
105.0 |
0.89 |
12.0 |
0.97 |
9.7 |
0.83 |
8.3 |
0.83 |
8.0 |
0.75 |
47.3 |
1.10 |
56.7 |
1.16 |
500 |
21.0 |
0.79 |
26.3 |
1.08 |
86.7 |
0.94 |
113.0 |
0.96 |
11.7 |
0.95 |
9.7 |
0.83 |
8.0 |
0.80 |
9.7 |
0.91 |
43.3 |
1.01 |
55.3 |
1.13 |
160 |
20.0 |
0.75 |
24.0 |
0.99 |
99.7 |
1.08 |
104.3 |
0.89 |
9.7 |
0.78 |
13.3 |
1.14 |
8.7 |
0.87 |
12.0 |
1.13 |
46.3 |
1.08 |
49.3 |
1.01 |
50 |
21.7 |
0.81 |
24.0 |
0.99 |
95.7 |
1.03 |
122.0 |
1.04 |
12.7 |
1.03 |
9.3 |
0.80 |
9.0 |
0.90 |
10.0 |
0.94 |
48.7 |
1.13 |
55.7 |
1.14 |
16 |
27.7 |
1.04 |
28.0 |
1.15 |
91.7 |
0.99 |
111.3 |
0.95 |
11.0 |
0.89 |
9.3 |
0.80 |
10.0 |
1.00 |
9.7 |
0.91 |
43.7 |
1.02 |
53.7 |
1.10 |
NPD (4µg) |
323.3 |
13.66 |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
SAZ (2µg) |
– |
– |
– |
– |
1744.0 |
18.82 |
– |
– |
1458.7 |
118.27 |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
9AA (50µg) |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
622.7 |
98.32 |
– |
– |
– |
– |
– |
– |
MMS (2µL) |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
1085.3 |
25.24 |
– |
– |
2AA (2µg) |
– |
– |
2666.7 |
126.98 |
– |
– |
3162.7 |
33.65 |
– |
– |
178.0 |
19.78 |
– |
– |
183.3 |
16.18 |
– |
– |
– |
– |
2AA(50µg) |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
241.0 |
4.99 |
Applicant's summary and conclusion
- Conclusions:
- No mutagenic effect was observed for the test substance tested up to cytotoxic concentration in any of the test strains without and with metabolic activation. The test substance is non-mutagenic in test strains used.
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