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EC number: 203-142-3 | CAS number: 103-76-4
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- May 1983/ Revised Draft, March 1996
- Deviations:
- yes
- Remarks:
- (2-aminoanthracene was the only used positive control in experiments with metabolic activation)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
- Version / remarks:
- Date of deletion: 21 July 1997 (Method merged with TG 471)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- December 1992
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-piperazin-1-ylethanol
- EC Number:
- 203-142-3
- EC Name:
- 2-piperazin-1-ylethanol
- Cas Number:
- 103-76-4
- Molecular formula:
- C6H14N2O
- IUPAC Name:
- 2-piperazin-1-ylethanol
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- - Batch No.: 25-7626
- storage: room temperature
Method
- Target gene:
- his and trp operon
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- other: defective excision repair system
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix from Aroclor 1254 treated male Sprague-Dawley rats.
- Test concentrations with justification for top dose:
- 0, 20, 100, 500, 2500 and 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
- Justification for choice of solvent/vehicle: good solubility
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: with S-9 mix: all strains 2-aminoanthracene; without S-9 mix: strains TA100, TA1535: N-methyl-N'-nitro-N-nitrosoguanidine; TA98: 4-nitro-o-phenylendiamine; TA1537: 9-aminoacridine; E.coli WP2 uvrA: N-ethyl-N'-nitro-N-nitrosoguanidine.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 - 72 h
NUMBER OF REPLICATIONS: 3
METHOD OF APPLICATION: standard plate test
DURATION
- Exposure duration: 48 - 72 h
NUMBER OF REPLICATIONS: 3 - Evaluation criteria:
- The test chemical is considered positive in this assay if the following criteria are met: A dose-related and reproducible increase in the number of revertant colonies, i.e. about doubling of the spontaneous mutation rate in at least one tester strain either without S-9 mix or after adding a metabolizing system.
A test substance is generally considered non-mutagenic in this test if: The number of revertants for all tester strains were within the historical negative control range under all experimental conditions in two experiments carried out independently of each other.
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:
- cytotoxicity
- Remarks:
- A slight decrease of revertants was occasionally observed from 2500 µg/plate onwards.
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- A slight decrease of revertants was occasionally observed from 2500 µg/plate onwards.
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- A slight decrease of revertants was occasionally observed from 2500 µg/plate onwards.
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- A slight decrease of revertants was occasionally observed from 2500 µg/plate onwards.
- Vehicle controls validity:
- valid
- 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
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No Test substance precipitation was found.
Any other information on results incl. tables
Standard plate test:
Dose (µg/plate) | TA1535 | TA100 | TA1537 | TA98 | E coli. WP2 uvrA | |||||
|
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
0 |
20±2 |
21±2 |
140±17 |
151±14 |
14±1 |
16±2 | 32±5 | 39±4 | 32±2 | 42±5 |
20 | 20±1 | 21±1 | 154±7 | 151±16 | 11±2 | 13±2 | 33±4 | 41±7 | 33±3 | 37±3 |
100 | 19±1 | 20±2 | 145±9 | 147±12 | 10±3 | 10±1 | 32±3 | 43±7 | 31±1 | 39±3 |
500 | 22±2 | 20±2 | 147±19 | 139±11 | 10±0 | 10±1 | 34±7 | 29±2 | 29±1 | 38±2 |
2500 | 21±1 | 13±2 | 127±6 | 136±7 | 11±1 | 9±1 | 28±3 | 27±4 | 27±5 | 35±4 |
5000 | 20±1 | 11±1 | 140±6 | 140±6 | 8±2 | 11±3 | 31±3 | 22±5 | 27±3 | 33±3 |
2-AA | - | 223±13 | - | 1431±6 | - | 118±4 | - | 1005±9 | - | 266±37 |
MNNG | 1119±105 | - | 1025±56 | - | - | - | - | - | - | - |
AAC | - | - | - | - | 307±4 | - | - | - | - | - |
NPD | - | - | - | - | - | - | 1011±7 | - | - | - |
ENNG | - | - | - | - | - | - | - | - | 512±13 | - |
Mean ± SD
Preincubation test:
Dose (µg/plate) | TA1535 | TA100 | TA1537 | TA98 | E. coli WP2 uvrA | ||||||
-S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | ||
0 | 21±3 | 22±4 | 140±6 | 160±1 | 10±1 | 12±0 | 31±1 | 45±1 | 36±1 | 50 ± 2 | |
20 | 19±3 | 18±3 | 144±11 | 158±3 | 11±2 | 11±1 | 29±3 | 45±2 | 34±2 | 52 ± 6 | |
100 | 21±2 | 20±4 | 142±7 | 153±8 | 10±1 | 9±2 | 24±4 | 40±2 | 31±3 | 47 ± 2 | |
500 | 21±2 | 17±2 | 160±11 | 155±5 | 10±2 | 12±2 | 26±1 | 43±3 | 34±4 | 44 ± 4 | |
2500 | 17±2 | 16±1 | 169±10 | 162±8 | 9±2 | 9±3 | 29±5 | 38±2 | 31±5 | 44 ± 6 | |
5000 | 16±2 | 10±2 | 158±16 | 161±1 | 8±2 | 9±2 | 26±2 | 45±2 | 32±5 | 42 ± 6 | |
2-AA | - | 149±11 | - | 1484±45 | - | 174±23 | - | 1226±163 | - | 223 ±25 | |
MNNG | 1644±231 | - | 2034±58 | - | - | - | - | - | - | - | |
AAC | - | - | - | - | 712±11 | - | - | - | - | - | |
NPD | - | - | - | - | - | - | 1281±64 | - | - | - | |
ENNG | - | - | - | - | - | - | - | - | 670±44 | - |
Mean ± SD
2-AA: 2-aminoanthracene;
MNNG; N-methyl-N-nitro-N-nitrosoguanidine
ENNG; N-ethyl-N-nitro-N-nitrosoguanidine
NPD: 4-nitro-o-phenylendiamine
AAC: 9-aminoacridine chloride monohydrate
Applicant's summary and conclusion
- Conclusions:
- neagtive Ames test
- Executive summary:
A study according to OECD TG 471 was conducted to assess the in vitro gene mutation potential of the test item in different bacteria strains (TA 1537, TA 1535, TA 98, TA 100 and E. coli WP uvrA). In the preincubation method bacteria were preincubated for 20 min with the test item using concentrations of 20, 100, 500, 2500 and 5000 µg/plate. Water was used as solvent control. Afterwards, bacterial were plates and exposed for 48 to 72 h. In the standard plate test the exposure duration was 48 to 72 hours as well. Incubation was done in the presence and in the absence of a metabolizing system (S9-Mix from Aroclor-1254 treated male rats). With regard to cytotoxicity, a slight decrease of revertants was occasionally observed from 2500 µg/plate onwards. No genotoxicity was observed neither in presence nor absence of S9-mix. The positive controls induced a significant increase in mutation frequency.
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