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EC number: 220-638-5 | CAS number: 2842-44-6
- 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:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-(N-methyl-p-toluidino)ethanol
- EC Number:
- 220-638-5
- EC Name:
- 2-(N-methyl-p-toluidino)ethanol
- Cas Number:
- 2842-44-6
- Molecular formula:
- C10H15NO
- IUPAC Name:
- 2-[methyl(4-methylphenyl)amino]ethan-1-ol
- Test material form:
- liquid: viscous
Constituent 1
Method
- Target gene:
- Histidine Mutation additional Mutations
hisG46 hisC3076 hisD3052 LFS Repair R Factor
TA1535 TA1537 rfa uvrB -
TA100 TA98 rfa uvrB +R
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver S9 mix
- Test concentrations with justification for top dose:
- ten doses of test article ranging from 5,000 to 6.67 µp per plate, one plate per dose, both in the presence and absence of S9 mix. Doses tested in the mutagenicity assay were selected based on the results of the dose rangefinding study conducted on the test article using tester strains TA 100 and WP2uvrA in both the presence and absence of S9 mix with one plate per dose. Ten doses of test article (from 5000 to 6.67 µg per plate) were tested and the results are presented in Tables I and 2. These data were generated in Experiment 20880-A1. Cytotoxicity was observed with tester strain at 5,000 µg per plate in the presence of S 9 mix and at 3,330 µg per plate and above in the absence of S9 mix as evidenced by a reduction in the number of revertants per plate and a slight thinning of the bacterial background lawn. No cytotoxicity was observed with tester strain WP2uvrA in either the presence or absence of S9 mix as evidenced by a normal background lawn and no decrease in the number or revetants per plate.
- Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- other: 2-aminoanthracene, ICR-191
- Evaluation criteria:
- The number of revertant colonies per plate for the vehicle, controls and all plates containing test article were counted manually. The number of revertant colonies per plate for the positive controls were counted by automated colony counter.
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:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- 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:
- Cytotoxicity was observed with tester strain at 5000 µg per plate in the presence of S9 mix and at 3330 µg per plate and above in the absence of S9 mix as evidenced by a reduction in the number of revertants per plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- 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
- Untreated negative controls validity:
- not valid
- True negative controls validity:
- not valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Test Article Handling
The test article, FIRSTCURE MHPT, was stored at room temperature. The test article formed an unworkable (non-homogeneous) suspension in water at a concentration of 99.6 mg per ml. The test article formed a solution in dimethlsulfoxide (DMSO) at aconcentration of 99.8 mg per ml. For this reason, DMSO (CAS# 67-68-5) was used as the vehicle. At 100 mg per ml, which was the most conccentrated stock dilution prepared for the mutagenicity assay, the test article formed a transparent colorless solution. The test article remained a solution in all succeeding dilutions prepared for the mutagenicity assay
B. Dose Range finding Study
Doses tested in the mutagenicity assay were based on the results of the dose rangefinding study conducted on the test article using and WP2uvrA in both the presence and absence of S9 mix with one plate per dose. Ten doses of test article (from 5000 to 6.67 µg per plate) were tested and the results are presented in Tables I and 2.These data were generated in Experiment 20880-AI .Cytotoxicity was observed with tester strain T100 at 5000 µg per plate in the presence of S9 mix and at 3330 µg per plate and above in the absence of S9 mix as evidenced by a reduction in the number of revertants per plate and a slight thinning of the bacterial background lawn. No cytotoxicity was observed with tester strain WP2uvrA in either the presence or absence of S9 mix as evidenced by a normal background lawn and no decrease in the number or revetants per plate.
c. Mutagenicity Assay
The mutagenicity assay results for FIRSTCURE MHPT are presented in Tables 3 and 4.These data were generated in Experiment 20880-BI.The data are presented as individual plate counts (Table 3) and as mean revertants per plate ± standard deviation (Table 4) for each treatrnent and control group.
The results of the dose range finding study were used to select the six doses tested in the assay. The doses tested with all tester strains were 5000, 3330, 1000, 333, 100, and 33,3 pg per plate in both the presence and absence of S9 mix.
In Experiment 20880-Bl (Tables 3 and 4), all data were acceptable and no positive increases in the mean number of revenants per plate were observed with any of the tester strains in either the presence of absence of S9 mix.
All criteria for a valid study were fulfild.
Applicant's summary and conclusion
- Conclusions:
- The results of the Salmonella Escherichia coli/Mammalian-Microsome Reverse Mutation Assay indicate that under the conditions of this study, ChemFirst, Inc.'s test article, MHPT, did not cause a positive increase in the mean number of revenants per plate with any of the tester strains either in the presence or absence of microsomal enzymes prepared from Aroclor- induced rat liver (S9)
- Executive summary:
At the request of ChemFirst, Inc., Covance investigated MHPT for Mutagenic activity in the Salmonella - Escherichia coli Reverse Mutation Assay. This assay evaluated the test article and/or its metabolites for their abi!ity of induce reverse mutations at the histidine locus in the genome of specific Salmonella typhimurium tester strains and at the tryptophan locus in Echerichia coli tester strain both in the presence and absence of an exogenous metabolic activation system of mammalian microscpal enzymes derived from AroclorTM-induced rat liver (S9). The doses tested in the mutagenicity assay were selected based on the results of a dose rangefinding study using tester strains TA100 and WP2uvrA and ten doses of test article ranging from 5000 to 6.67 µp per plate, one plate per dose, both in the presence and absence of S9 mix. The tester strains used in the mutagenicity assay were Salmonella typhimurium tester strains TA98, TA 100, TA1 535, TA1537, and Escherichia coli tester strain WP2uvrA. The assay was conducted with six doses of test article in both the presence and absence of S9 mix along with concurrent vehicle and positive controls using three piates per dose. The doses tested with all tester strains were 5000, 3330, 1000, 333, 100 and 33.3 µg per plate in both the presence and absence of S9 mix. The results of the Salmonella - Escherichia coli/ Reverse Mutation Assay indicate that under the conditions of this study, ChemFirst, Inc.'s test article, MHPT, did rot cause a positive increase in the mean number of revertants per plate with any of the tester strains either in the presence or absence of microsomal enzymes prepared from Aroclor induced rat liver (S9).
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