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EC number: 408-090-7 | CAS number: 100418-33-5 METHYLGELB
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- other: in vitro mammalian cell gene mutation tests using the thymidine kinase gene (migrated information)
Test material
- Reference substance name:
- 2-((4-methyl-2-nitrophenyl)amino)ethanol
- EC Number:
- 408-090-7
- EC Name:
- 2-((4-methyl-2-nitrophenyl)amino)ethanol
- Cas Number:
- 100418-33-5
- Molecular formula:
- C9H12N2O3
- IUPAC Name:
- 2-[(4-methyl-2-nitrophenyl)amino]ethan-1-ol
- Test material form:
- solid: crystalline
- Details on test material:
- red powder
Batch # : 6718 Fass 10/20
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- 31.3, 62.5, 125.0, 250.0, 375.0, 500.0 µg/ml Experiment I (treatment for 4 h; with and without metabolic activation)
62.5, 125.0, 250.0, 300.0, 350.0 µg/ml Experiment Ia (treatment for 4 h; with and without metabolic activation)
31.3, 62.5, 125.0, 250.0, 375.0 µg/ml Experiment II (treatment for 24 h; without metabolic activation) - Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Remarks:
- medium
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
Results and discussion
Test resultsopen allclose all
- Species / strain:
- mouse lymphoma L5178Y cells
- Remarks:
- experiment I
- Metabolic activation:
- without
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at concentrations >= 250 µg/ml
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- not valid
- Species / strain:
- mouse lymphoma L5178Y cells
- Remarks:
- Experiment I
- Metabolic activation:
- with
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at concentrations >= 125 µg/ml
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- not valid
- Species / strain:
- mouse lymphoma L5178Y cells
- Remarks:
- Experiment Ia
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at concentrations >= 300 µg/ml
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- mouse lymphoma L5178Y cells
- Remarks:
- Experiment Ia
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at concentrations >= 250 µg/ml
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- mouse lymphoma L5178Y cells
- Remarks:
- Experiment II
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at concentrations >= 250 µg/ml
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- not determinable
Applicant's summary and conclusion
- Conclusions:
- Hydroxyethyl-2-nitro-p-toluidine did neither in the absence nor in the presence of metabolic activation induce a biological relevant increase in mutations in the mouse lymphoma thymidine kinase locus assay in L5178Y cells under the described test conditions. Hence no indication was found in this experiment that Hydroxyethyl-2-nitro-p-toluidine might cause gene or chromosomal mutations in mammalian cells. Hydroxyethyl-2-nitro-p-toluidine is thus evaluated to be non-mutagenic in this in vitro mammalian cell mutagenicity test.
- Executive summary:
Hydroxyethyl-2-nitro-p-toluidine was examined for its mutagenic activity in the L5178Y TK+/- mouse lymphoma assay in the absence and presence of metabolic activation. Mutation is detected in this test system by examining the occurrence of trifluorothymidine (TFT) resistance that is caused by forward mutation at the thymidine kinase (TK) locus. The test was performed with and without metabolic activation (S9 mix from the liver of phenobarbital/ß-naphthoflavone induced male Wistar HanIbm rats). A range-finding test (pre-test on toxicity, measuring relative suspension growth) and two independent mutagenicity xperiments were carried out. Culture medium and DMSO were used as negative and solvent controls, while cyclophosphamide (CPA; 3 µg/ml) and methyl methane sulphonate (MMS; 13 µg/ml) were used as positive controls with and without metabolic activation system, respectively. In experiment I, the cells were incubated with the test item for 4 hours in the presence and absence of S9 mix. In experiment II the incubation time was 24 hours in the absence of S9 mix. Two replicate cultures were investigated for each concentration and test group. Mutant frequency and cell survival (measured as cloning efficiency) were determined in parallel. In order to determine the ratio of small versus large colonies, the colonies were evaluated with regard to size/optical density. In the initial range-finding study, concentrations of up to 10 mM (from 15 to 2000 µg/ml) with and without S9 mix were evaluated for toxicity. Toxicity was noted at 62.5 µg/ml and above in the absence of S9 mix (relative suspension growth of 60.4 to 12.0 %) and at 250 µg/ml and above (relative suspension growth 42.8 % to 4.6 %) in the presence of S9 mix (4 hours treatment). After 24 h of treatment in the absence of S9 mix, the cell growth was distinctly reduced (relative cell growth of 9.6 % to 3.7 %) at 500 µg/ml and above. Based on these findings, 6 concentrations covering a range of 3.0 to 500 µg/ml with without S9 mix were chosen for the main experiments. Five of these 6 concentrations were evaluated in each experiment. In the first experiment an increase in mutation frequency (induction factor of 2.5) in one culture without S9 was noted at a concentration which showed toxic effects (82% toxicity). However, no evidence for an increase in mutation frequency was seen in the parallel culture. It is important to note that the next higher dose of 375 ug/ml was excessively toxic (96% toxicity) and the 500 ug/ml concentration was excluded from evaluation due to severe toxicity. No effects on the mutation rate were seen in the experiment with metabolic activation. As the positive control failed to respond in the second culture (in the presence of S9-mix), the whole experiment was repeated and was reported as experiment Ia. Due to the severe toxicity observed at 500 µg/ml and the steep toxicity gradient in experiment I, the dose range was adapted and in experiment Ia by using narrowly spaced concentrations in the critical concentration range. In experiment Ia (4 hour treatment with and without S9 mix) as well as in experiment II (24 hour treatment without S9 mix) no substantial and reproducible dose dependent increase of the mutation frequency was noted with Hydroxyethyl-2-nitro-p-toluidine. Even at highly toxic doses only very slight increases were seen which remained within the historical negative control range and were considered not to be biological relevant. The ratio of small to large colonies was not affected by the treatment with Hydroxyethyl-2-nitro-p-toluidine. The positive controls demonstrated that the system was able to detect known mutagens.
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