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EC number: 221-359-1 | CAS number: 3077-12-1
- 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:
- 26 Oct - 17 Nov 1998
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- (non-standard positive controls were used, which are not recommended in the guideline; single plates were used per concentration instead of triplicate plating)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted in 1997
- Deviations:
- yes
- Remarks:
- (non-standard positive controls were used, which are not recommended in the guideline; single plates were used per concentration instead of triplicate plating)
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2,2'-[(4-methylphenyl)imino]bisethanol
- EC Number:
- 221-359-1
- EC Name:
- 2,2'-[(4-methylphenyl)imino]bisethanol
- Cas Number:
- 3077-12-1
- Molecular formula:
- C11H17NO2
- IUPAC Name:
- 2,2'-[(4-methylphenyl)imino]diethanol
Constituent 1
Method
- Target gene:
- his operon
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with Aroclor 1254
- Test concentrations with justification for top dose:
- Pre-test for toxicity/Experiment I (plate incorporation): 16, 50, 160, 500, 1600 and 5000 µg/plate with and without metabolic activation
Experiment II (preincubation method): 16, 50, 160, 500, 1600 and 5000 µg/plate with and without metabolic activation - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The test substance was soluble in DMSO and formed a clear colorless solution.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- sodium azide
- cumene hydroperoxide
- other: 2-aminoanthracene: +S9, 3 µg/plate for all strains; nitrofurantoin: - S9, 0.2 µg/plate for TA100; 4-nitro-1,2-phenylene diamine: -S9, 0.5 and 10 µg/plate for TA1537 and TA98, respectively
- Remarks:
- Each batch of S9 mix was checked for its metabolizing capacity by using reference mutagenes (not further specified); appropriate activity was demonstrated.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation, Experiment I); preincubation (Experiment II)
DURATION
- Preincubation period: 20 min (Experiment II)
- Exposure duration: 48 h (Experiment I and II)
NUMBER OF REPLICATIONS: Single plates per concentration each in two independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: background growth, marked and dose-dependent reduction in mutant count, titre count - Evaluation criteria:
- A reproducible and dose-related increase in mutant counts of at least one strain is considered to be a positive result. For TA1535, TA100 and TA98 this increase should be about twice that of negative controls, whereas for TA1537, at least a threefold increase should be reached. For TA102 an increase about 150 mutants should be reached. Otherwise, the result is evaluated as negative. However, these guidelines may be overruled by good scientific judgement. In case of questionable results, investigations should continue, possibly with modifications, until a final evaluation is possible.
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:
- at 5000 µg/plate with and without metabolic activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- 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:
- at 5000 µg/plate with and without metabolic activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- 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:
- at 5000 µg/plate with and without metabolic activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- 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:
- at 5000 µg/plate with and without metabolic activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 160 and 500 µg/plate with and without metabolic activation, respectively
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Precipitation of the test substance was not observed.
RANGE-FINDING/SCREENING STUDIES: Experiment I (plate incorporation) served as pre-test for toxicity.
HISTORICAL CONTROL DATA
Only single plates were counted in the present study for each control and concentration level. Moreover only mean values without standard deviation were given in the historical control data, therefore it cannot be confirmed if the positive or negative control values are within the range of the historical control data. However, the positive control values from the study and from the historical control data increased mutant counts well over those of the negative controls.
Any other information on results incl. tables
Table 1 Results of Experiment I (plate incorporation)
With or without S9-Mix | Test substance concentration (μg/plate) | Revertant colonies per plate | ||||
Base-pair substitution type | Frameshift type | |||||
TA100 | TA1535 | TA102 | TA98 | TA1537 | ||
– | DMSO | 64 | 11 | 115 | 9 | 9 |
– | 16 | 63 | 10 | 139 | 9 | 8 |
– | 50 | 75 | 11 | 131 | 16 | 14 |
– | 160 | 71 | 9 | 162 | 11 | 6 |
– | 500 | 68 | 9 | 109 | 9 | 8 |
– | 1600 | 77 | 12 | 93B | 11 | 5 |
5000 | 77 | 14 | 60B | 8 | 4 | |
Positive controls, –S9 | Name | NF | SA | Cumene | 4-NPDA | 4-NPDA |
Concentrations (μg/plate) | 0.2 | 10 | 50 | 0.5 | 10 | |
Revertant colonies per plate | 293 | 714 | 277 | 148 | 129 | |
+ | DMSO | 141 | 9 | 203 | 31 | 12 |
+ | 16 | 96 | C | 195 | 14 | 16 |
+ | 50 | 104 | 7 | 198 | 27 | 17 |
+ | 160 | 104 | 10 | 151 | 35 | 9 |
+ | 500 | 119 | 6 | 161B | 28 | 8 |
+ | 1600 | 145 | 11 | 117B | 31 | 5 |
+ | 5000 | 145 | 5 | 51B | 18 | 2 |
Positive controls, –S9 | Name | 2-AA | 2-AA | 2-AA | 2-AA | 2-AA |
Concentrations (μg/plate) | 3 | 3 | 3 | 3 | 3 | |
Revertant colonies per plate | 1658 | 379 | 492 | 1214 | 382 |
NF = Nitrofurantoin
SA = Sodium azide
Cumene = Cumene hydroperoxide
4-NPDA = 4-Nitro-1,2-phenylene diamine
2AA = 2-Aminoanthracene
C = contaminated
B = reduced background lawn
Table 2: Results of Experiment II (preincubation method)
With or without S9-Mix | Test substance concentration (μg/plate) | Revertant colonies per plate | ||||
Base-pair substitution type | Frameshift type | |||||
TA100 | TA1535 | TA102 | TA98 | TA1537 | ||
– | DMSO | 73 | 14 | 178 | 16 | 7 |
– | 16 | 96 | 14 | 216 | 22 | 7 |
– | 50 | 100 | 8 | 211 | 18 | 11 |
– | 160 | 72 | 6 | 215 | 16 | 7 |
– | 500 | 114 | 8 | 202 | 19 | 9 |
– | 1600 | 106 | 9 | 179 | 18 | 4 |
5000 | 83B | 5B | 75B | 5B | 2B | |
Positive controls, –S9 | Name | NF | SA | Cumene | 4-NPDA | 4-NPDA |
Concentrations (μg/plate) | 0.2 | 10 | 50 | 0.5 | 10 | |
Revertant colonies per plate | 347 | 650 | 523 | 152 | 146 | |
+ | DMSO | 125 | 9 | 239 | 27 | 9 |
+ | 16 | 94 | 12 | 266 | 22 | 13 |
+ | 50 | 101 | 12 | 237 | 19 | 9 |
+ | 160 | 112 | 10 | 266 | 22 | 11 |
+ | 500 | 133 | 8 | 252 | 16 | 11 |
+ | 1600 | 155 | 13 | 168 | 9 | 8 |
+ | 5000 | 151B | 10B | 79B | 17B | 3B |
Positive controls, –S9 | Name | 2-AA | 2-AA | 2-AA | 2-AA | 2-AA |
Concentrations (μg/plate) | 3 | 3 | 3 | 3 | 3 | |
Revertant colonies per plate | 1798 | 198 | 439 | 1587 | 184 |
NF = Nitrofurantoin
SA = Sodium azide
Cumene = Cumene hydroperoxide
4-NPDA = 4-Nitro-1,2-phenylene diamine
2AA = 2-Aminoanthracene
C = contaminated
B = reduced background lawn
Table 3: Historical control values (January - December 1996): plate incorporation
With or without S9-Mix | Compound | TA100 | TA1535 | TA102 | TA98 | TA1537 |
– | DMSO | 86 | 9 | 292 | 20 | 8 |
– | SA | -- | 739 | -- | -- | -- |
– | NF | 253 | -- | -- | -- | -- |
– | 4-NPDA | -- | -- | -- | 155 | 139 |
– | Cumene | -- | -- | 624 | -- | -- |
+ | DMSO | 103 | 11 | 340 | 30 | 10 |
+ | 2-AA | 1540 | 204 | 829 | 1461 | 281 |
NF = Nitrofurantoin
SA = Sodium azide
Cumene = Cumene hydroperoxide
4-NPDA = 4-Nitro-1,2-phenylene diamine
2AA = 2-Aminoanthracene
Table 4: Historical control values (January - December 1996): preincubation method
With or without S9-Mix | Compound | TA100 | TA1535 | TA102 | TA98 | TA1537 |
– | DMSO | 80 | 9 | 271 | 22 | 8 |
– | SA | -- | 747 | -- | -- | -- |
– | NF | 278 | -- | -- | -- | -- |
– | 4-NPDA | -- | -- | -- | 183 | 127 |
– | Cumene | -- | -- | 602 | -- | -- |
+ | DMSO | 94 | 11 | 337 | 28 | 8 |
+ | 2-AA | 1318 | 172 | 601 | 1239 | 164 |
NF = Nitrofurantoin
SA = Sodium azide
Cumene = Cumene hydroperoxide
4-NPDA = 4-Nitro-1,2-phenylene diamine
2AA = 2-Aminoanthracene
Applicant's summary and conclusion
- Conclusions:
- Based on the results of the conducted study, the test substance was not considered to reveal mutagenic properties in Salmonella typhimurium strains TA1535, TA1537, TA89, TA100 and TA102 with and without metabolic activation, respectively.
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