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EC number: 278-169-7 | CAS number: 75277-39-3
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Sep 2012 - Dec 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Version / remarks:
- 21 July 1997
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- 4-(2-hydroxyethyl)piperazin-1-ylethanesulphonic acid
- EC Number:
- 230-907-9
- EC Name:
- 4-(2-hydroxyethyl)piperazin-1-ylethanesulphonic acid
- Cas Number:
- 7365-45-9
- Molecular formula:
- C8H18N2O4S
- IUPAC Name:
- 2-[4-(2-hydroxyethyl)piperazin-1-yl]ethanesulfonic acid
Constituent 1
Method
- Target gene:
- TK locus
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- - Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically "cleansed" against high spontaneous background: yes
- Metabolic activation:
- with and without
- Metabolic activation system:
- Due to migration, the value was transferred to one of the current document's attachments
- Test concentrations with justification for top dose:
- 100, 500, 1000, 1500 and 2384 µg/mL (with and without S9 mix)
- Vehicle / solvent:
- - Vehicle used: sterile distilled water
- Justification for choice of vehicle: standard vehicle
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 7,12-dimethylbenzanthracene
- methylmethanesulfonate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 4 h
SELECTION AGENT: trifluorothymidine
NUMBER OF REPLICATIONS: 2
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth - Evaluation criteria:
- In evaluation of the data, increases in induced mutant frequency that occurred only at highly toxic concentrations (i.e., less than 10 % total growth) were not considered biologically relevant. All conclusions were based on scientific judgement; however, the following criteria are presented as a guide to interpretation of the data:
A result was considered positive if a concentration-related increase in induced mutant frequency was observed in the treated cultures and one or more treatment conditions with 10 % or greater total growth exhibited induced mutant frequencies of >= 90 mutants per 10E6 clonable cells (based on the average mutant frequency of duplicate cultures). If the average solvent control mutant frequency was >90 mutants per 10E6 clonable cells, a doubling of mutant frequency over the background will also be required.
A result was considered negative if the treated cultures exhibited induced mutant frequencies of less than 90 mutants per 10E6 clonable cells (based on the average mutant frequency of duplicate cultures) and there was no concentration-related increase in mutant frequency.
There are some situations in which a chemical would be considered negative when there was no culture showing between 10 - 20 % survival:
1) There was no evidence of mutagenicity (e.g. no dose response or increase in induced mutant frequencies between 45 and 89 mutants per 10E6) in a series of data points within 100 % to 20% survival and there was at least one negative data point between 20 % and 25 % survival.
2) There was no evidence of mutagenicity (e.g., no dose response or increase in induced mutant frequencies between 45 and 89 mutants per 10E6) in a series of data points between 100 % to 25 % survival and there was also a negative data point between 10 % and 1 % survival. In this case it would be acceptable to count the TFT colonies of cultures exhibiting < 10 % total growth. - Statistics:
- none applied
Results and discussion
Test results
- Key result
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: No
- Effects of osmolality: No
- Evaporation from medium: No
- Water solubility: No
- Precipitation: No
STUDY RESULTS
please refer to "Any other information on results"
HISTORICAL CONTROL DATA
- Positive historical control data: please refer to "Any other information on results"
- Negative (vehicle) historical control data: please refer to "Any other information on results"
Any other information on results incl. tables
DATA SUMMARY FOR L5178Y/TK+/-MOUSE LYMPHOMA CELLS TREATED WITH THE TEST ITEM
IN THE ABSENCE OF EXOGENOUS METABOLIC ACTIVATION
Mutagenicity Assay (4-hour exposure)
DOSE LEVEL (µg/mL) | PRECIP. |
%SUSP.GROWTH | VC COLONIES | TFT COLONIES | TOTAL MUTANT FREQUENCY(PER 10E6 CELLS) | INDUCED MUTANT FREQUENCY(PER 10E6 CELLS) |
% RELATIVE TOTAL GROWTH |
| |||||||
PLATECOUNTS | PLATECOUNTS |
| |||||||||||||
1 2 3 | MEAN | 1 2 3 | MEAN |
|
|
|
| ||||||||
SOLVENTA |
|
100 | 216 | 224 | 197 | 212 | 51 | 83 | 36 | 57 | 53 |
N/A |
100 | ||
SOLVENTB |
| 292 | 195 | 199 | 229 | 69 | 38 | 49 | 52 | 45 | |||||
100A |
| 103 | 220 | 195 | 151 | 189 | 31 | 24 | 32 | 29 | 31 | -19 | 88 | ||
100B |
| 115 | 287 | 155 | 186 | 209 | 35 | 40 | 23 | 33 | 31 | -18 | 109 | ||
500A |
| 109 | 249 | 158 | 184 | 197 | 35 | 35 | 40 | 37 | 37 | -12 | 98 | ||
500B |
| 107 | 260 | 159 | 180 | 200 | 26 | 49 | 35 | 37 | 37 | -13 | 97 | ||
1000A |
| 96 | 281 | 203 | 159 | 214 | 36 | 23 | 30 | 30 | 28 | -22 | 93 | ||
1000B |
| 99 | 273 | 161 | 207 | 214 | 17 | 24 | 36 | 26 | 24 | -25 | 96 | ||
1500A |
| 107 | 231 | 163 | 161 | 185 | 41 | 23 | 45 | 36 | 39 | -10 | 89 | ||
1500B |
| 99 | 178 | 190 | 195 | 188 | 44 | 56 | 41 | 47 | 50 | 1 | 85 | ||
2384A |
| 113 | 244 | 201 | 214 | 220 | 38 | 26 | 38 | 34 | 31 | -18 | 112 | ||
2384B |
| 93 | 207 | 150 | 212 | 190 | 68 | 39 | 58 | 55 | 58 | 9 | 80 | ||
|
| ||||||||||||||
20 |
| 56 | 77 | 47 | 78 | 67 | 166 | 132 | 128 | 142 | 422 | 372 | 17 | ||
15 |
| 65 | 89 | 94 | 90 | 91 | 190 | 168 | 162 | 173 | 381 | 332 | 27 |
DATA SUMMARY FOR L5178Y/TK+/-MOUSE LYMPHOMA CELLS TREATED WITH THE TEST ITEM
IN THE PRESENCE OF EXOGENOUS METABOLIC ACTIVATION
Mutagenicity Assay (4-hour exposure)
DOSE LEVEL (µg/mL) | PRECIP. |
%SUSP.GROWTH | VC COLONIES | TFT COLONIES | TOTAL MUTANT FREQUENCY(PER 10E6 CELLS) | INDUCED MUTANT FREQUENCY(PER 10E6 CELLS) |
%RELATIVE TOTAL GROWTH |
| |||||||
PLATE COUNTS | PLATE COUNTS |
| |||||||||||||
1 2 3 | MEAN | 1 2 3 | MEAN |
|
|
|
| ||||||||
SOLVENTA |
|
100 | 238 | 260 | 181 | 226 | 47 | 63 | 71 | 60 | 53 |
N/A |
100 | ||
SOLVENTB |
| 226 | 219 | 221 | 222 | 56 | 46 | 46 | 49 | 44 | |||||
100A |
| 122 | 242 | 205 | 188 | 212 | 53 | 33 | 24 | 37 | 35 | -14 | 115 | ||
100B |
| 131 | 269 | 206 | 221 | 232 | 37 | 52 | 54 | 48 | 41 | -8 | 135 | ||
500A |
| 133 | 310 | 234 | 181 | 242 | 66 | 44 | 35 | 48 | 40 | -9 | 144 | ||
500B |
| 130 | 241 | 182 | 197 | 207 | 23 | 35 | 28 | 29 | 28 | -21 | 120 | ||
1000A |
| 124 | 261 | 200 | 201 | 221 | 47 | 32 | 32 | 37 | 34 | -15 | 122 | ||
1000B |
| 115 | 259 | 239 | 220 | 239 | 43 | 55 | 45 | 48 | 40 | -9 | 123 | ||
1500A |
| 112 | 245 | 190 | 169 | 201 | 60 | 49 | 18 | 42 | 42 | -7 | 101 | ||
1500B |
| 112 | 289 | 197 | 195 | 227 | 49 | 33 | 56 | 46 | 41 | -8 | 114 | ||
2384A |
| 103 | 235 | 185 | 189 | 203 | 32 | 40 | 59 | 44 | 43 | -6 | 94 | ||
2384B |
| 113 | 239 | 180 | 201 | 207 | 55 | 44 | 49 | 49 | 48 | -1 | 104 | ||
POSITIVE CONTROL: 7,12-dimethylbenz(a)anthracene (DMBA) (µg/mL) | |||||||||||||||
1.5 |
| 13 | 110 | 108 | 90 | 103 | 213 | 183 | 192 | 196 | 382 | 333 | 6 | ||
1.25 |
| 18 | 89 | 81 | 99 | 90 | 195 | 168 | 157 | 173 | 387 | 338 | 7 |
Historical Control data
| Non-Activated (4-Hour) | Non-Activated (24-Hour) | ||||
| Solvent Control | 15 μg/mL MMS | 20 μg/mL MMS | Solvent Control | 5.0 μg/mL MMS | 7.5 μg/mL MMS |
Mean MF | 50.1 | 443.6 | 636.7 | 55.9 | 386.3 | 564.2 |
SD | 16.1 | 135.7 | 208.7 | 21.4 | 196.9 | 195.1 |
Maximum | 108 | 1038 | 1678 | 120 | 1452 | 1498 |
Minimum | 20 | 219 | 233 | 20 | 155 | 217 |
| S9-Activated (4-Hour) | |||
| Solvent Control | 15 μg/mL MMS | Solvent Control | 5.0 μg/mL MMS |
Mean MF | 54.7 | 340 | 397.3 | 361.7 |
SD | 14.8 | 74.9 | 94.1 | 18.8 |
Maximum | 90 | 508 | 742 | 373 |
Minimum | 32 | 53 | 263 | 340 |
Solvent control (Fischer's medium, distilled water, saline, DMSO, ethanol, acetone or vehicle supplied by Sponsor)
MMS Methyl methanesulfonate
DMBA Dimethylbenz(a)anthracene
MF Mutant frequency per 10E6 clonable cells
SD Standard deviation
Applicant's summary and conclusion
- Conclusions:
- In a GLP-study according to OECD Test Guideline 476, the test item was concluded to be negative in the L5178Y/TK+/- Mouse Lymphoma Assay.
- Executive summary:
The test article was tested in the L5178Y/TK+/- Mouse Lymphoma Mutagenesis Assay in the absence and presence of metabolic activation with a 4-hour exposure. The mutagenesis assay was used to evaluate the mutagenic potential of the test article.
Sterile distilled water was used as the solvent in this study based on the Sponsor’s request and compatibility with the target cells. In the mutagenesis assay, the test article formed clear solutions in water from 0.005 to 23.84 mg/mL. The concentrations treated in the mutagenesis assay ranged from 0.5 to 2384 µg/mL for both the non-activated and S9-activated cultures with a 4-hour exposure (the maximum concentration evaluated approximated the 10 mM limit dose for this assay). No visible precipitate was observed at the beginning or end of treatment. The concentrations chosen for cloning were 100, 500, 1000, 1500 and 2384 µg/mL for both the non-activated and S9-activated cultures. No cloned cultures exhibited induced mutant frequencies ≥90 mutants per 10E6 clonable cells. There was no concentration-related increase in mutant frequency.
The trifluorothymidine-resistant colonies for the positive and solvent control cultures from the mutagenicity assay were sized according to diameter over a range from approximately 0.2 to 1.1 mm. The colony sizing for the MMS and DMBA positive controls yielded the expected increase in small colonies (verifying the adequacy of the methods used to detect small colony mutants) and large colonies.
Under the conditions of this study, the test article was concluded to be negative in the L5178Y/TK+/- Mouse Lymphoma Assay.
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