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EC number: 298-995-1 | CAS number: 93841-25-9
- 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:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 3-(2-hydroxyethyl)-p-phenylenediammonium sulphate
- EC Number:
- 298-995-1
- EC Name:
- 3-(2-hydroxyethyl)-p-phenylenediammonium sulphate
- Cas Number:
- 93841-25-9
- Molecular formula:
- C8H12N2O.H2O4S
- IUPAC Name:
- 2-(2,5-Diaminophenyl)ethanol sulfate (1:1)
Constituent 1
- Specific details on test material used for the study:
- Batch number : 36/37
Purity : 99.8a/a%
Method
- Target gene:
- Histidine locus
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- S. typhimurium TA 102
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver S9
- Test concentrations with justification for top dose:
- Pre-experiment : 3, 10, 33, 100, 333, 1000, 2500 and 5000 ug/plate
Experiment I and II : 33, 100, 333, 1000, 2500 and 5000 ug/plate
Experiment IIa : 1000, 1500, 2000, 2500, 3000, 3500, 4000 and 5000 ug/plate (TA100 without metabolic activation only)
In the pre-experiment the concentration range of the test item was 3-5000ug/plate. The pre-experiment is reported as part of experiment I since no relevant toxic effects were observed and 5000ug/plate was chosen as the maximum concentration. The concentration range included two logarithmic decades. - Vehicle / solvent:
- Deionised water
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: (4-nitro-o-phenylenediamine), [2-aminoanthracene]
- Details on test system and experimental conditions:
- For each strain and dose level, including the controls three plates were used.
The following materials were mixed in a test tube and poured onto the selective agar plates
- 100uL test solution at each dose level, solvent (negative control) or reference mutagen solution (positive control),
- 500uL S9 mix (for test with metabolic activation) or S9 mix substitution buffer (for test without metabolic activation),
- 100uL bacteria suspension
- 2000uL overlay agar
In the pre-incubation assay 100uL test solution, 500uL S9 mix/S9 mix substitution buffer and 100uL bacterial suspension were mixed in a test tube and incubated at 37 deg C for 60 minutes. After pre-incubation 2.0mL overlay agar (45 deg C) was added to each tube. The mixture was poured onto agar plates. After solidification the plates were incubated upside down for at least 48 hours at 37 deg c in the dark.
The colonies were counted using Petri Viewer Mk2 with the software program Ames Study Manager. - Evaluation criteria:
- A test item is considered as a mutagen if a biologically relevant increase in the number of revertants exceeding the threshold of twice (strains TA98, TA100, TA102) or thrice (strains TA1535, TA1537) the colony count of the corresponding solvent control is observed. A dose dependent increase is considered biologically relevant if the threshold is exceeded at more than one concentration. An increase exceeding the threshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment. A dose dependent increase in the number of revertant colonies below the threshold is regarded as an indication of a mutagenic potential if reproduced in an independent second experiment. However, whenever the colony counts remain within the historical range of negative and solvent controls such an increase is not considered biologically relevant.
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA1535, TA1537, TA98, TA100, TA102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Since the data of the controls in strain TA102 in experiment I were far above the historical control data of the laboratory, this part had to be repeated (reported as part of experiment I). Due to questionable results in experiment II in strain TA100 without metabolic activation, this part had to be repeated (reported as experiment IIa). Each concentration, including the controls, was tested in triplicate. The plates incubated with the test item showed normal background growth up to the highest concentration in all strains used with and without metabolic activation.
A reduction in the number of revertants occurred in experiment II with metabolic activation in strain TA1535 at 1000ug/plate and in strain TA1537 at 100ug/plate and 333ug/plate. Since this reduction is not dose dependent, it is not judged as a true toxic effect.
No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with the test item at any concentration level, neither in the presence nor in the absence of metabolic activation. A single increase of the revertant colonies was observed in experiment II in strain TA100 without metabolic activation. The number of colonies exceeded the threshold of twice (strain TA100) the number of the corresponding solvent control at 2500ug/plate. Since there was no dose dependency observed, the isolated finding at 2500ug/plate was considered questionable. It was therefore decided to perform a confirmatory experiment under identical conditions (TA100, pre-incubation assay without metabolic activation). This additional experiment showed no biologically relevant increases in revertant colony numbers. Consequently, the isolated increase that was seen in TA100 in experiment II is considered not to be biologically relevant.
Appropriate reference mutagens were used as positive controls. These showed a distinct increase in induced revertant colonies. The historical control range was slightly exceeded in the solvent control (experiments I and II) of strain TA102 with metabolic activation.
The historical control range was slightly exceeded in the solvent control (experiments I and II) of strain TA102 with metabolic activation. In experiment I the historical control range was slightly exceeded in strain TA1535 (negative control) without metabolic activation. Since this deviation is rather small, this effect is considered to be based upon biologically irrelevant fluctuations in the number of colonies. Also in strains TA100 and TA102 with metabolic activation the historical control range was slightly exceeded at 100 and 333ug/plate (TA102 experiment I) at 100ug/plate (TA102 experiment II) and at 1500 and 4000 ug/plate (TA100 experiment IIa). Since this deviation is rather small, this effect is considered to be based upon biologically irrelevant fluctuations in the number of colonies. Due to a new evaluation unit, new historical control data were evaluated from 80 experiments. Since this number of experiments is rather small, the range can be exceeded in some experiments.
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.
Applicant's summary and conclusion
- Conclusions:
- Under the test conditions employed hydroxyethyl-p-phenylenediamine sulfate did not induce gene mutations in bacteria.
- Executive summary:
The study was performed to investigate the potential og hydroxy-p-phenylenediamine sulfate to induce gene mutations according to the plate incorporation test (experiment I) and the pre-incubation test (experiment II) using the Salmonella typhimurium strains TA1535, TA1537, TA98, TA100, TA102. The ssay was performed with and without liver microsomal activation. Since the data of the controls in strain TA102 in experiment I were far above the historical control data of the laboratory, this part had to be repeated (reported as part of experiment I). Due to questionable results in experiment II in strain TA100 without metabolic activation, this part had to be repeated (reported as experiment IIa). Each concentration, including the controls, was tested in triplicate. The test item was tested at the following concentrations : Pre-experiment : 3, 10, 33, 100, 333, 1000, 2500 and 5000 ug/plate ; Experiment I and II : 33, 100, 333, 1000, 2500 and 5000 ug/plate ; Experiment IIa : 1000, 1500, 2000, 2500, 3000, 3500, 4000 and 5000 ug/plate. The plates incubated with the test item showed normal background growth up to the highest concentration in all strains used with and without metabolic activation. A reduction in the number of revertants occurred in experiment II with metabolic activation in strain TA1535 at 1000ug/plate and in strain TA1537 at 100ug/plate and 333ug/plate. Since this reduction is not dose dependent, it is not judged as a true toxic effect. No biologically relevant increase in revertant colony numbers of any of the five tester strains was observed following treatment with the test item at any concentration level, neither in the presence nor in the absence of metabolic activation. Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies. In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used. Therefore, hydroxyethyl-p-phenylenediamine sulfate is considered to be non-mutagenic in this Salmonella typhimurium reverse mutation assay.
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