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Diss Factsheets
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EC number: 204-419-1 | CAS number: 120-71-8
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: well performed research study
Data source
Reference
- Reference Type:
- publication
- Title:
- Reproducibility of Microbial Mutagenicity Assays
- Author:
- V.C. Dunkel, E.Zeiger, D. Brunsick, E. McCoy, D. McGregor, K.Mortelmans, H.S. Rosenkranz, V.F. Simmon
- Year:
- 1 985
- Bibliographic source:
- Environm. Mutag, Volume 7, Suppl. 5: 1-248 (1985)
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Dunkel et al, Tests with Salmonella typhimurium and Escherichia coli using a standardized protocol, Environm. Mutag. 6 (Suppl. 2): 1 - 251
- Deviations:
- not specified
- Principles of method if other than guideline:
- four-laboratory study, plate-incorporation procedure
- GLP compliance:
- not specified
- Type of assay:
- bacterial gene mutation assay
Test material
- Reference substance name:
- 6-methoxy-m-toluidine
- EC Number:
- 204-419-1
- EC Name:
- 6-methoxy-m-toluidine
- Cas Number:
- 120-71-8
- Molecular formula:
- C8H11NO
- IUPAC Name:
- 2-methoxy-5-methylaniline
- Details on test material:
- - Name of test material (as cited in study report): p-Cresidine
- Analytical purity: 98.9 %
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 1538
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-Mix of hamster-, mouse and rat liver with and without Aroclor 1254 induction
- Test concentrations with justification for top dose:
- Dose ranges tested based on the solubility and toxicity of the test chemicals, but did not exceed 10.0 mg/plate. Individual doses tested were from 0.3 to 10000 µg/plate.
- Vehicle / solvent:
- DMSO (dimethyl sulfoxide) or ethanol (95% ethanol)
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO (dimethyl sulfoxide) or ethanol (95% ethanol)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-nitrofluorene, 2-aminoanthracene, sodium azide, 9-aminoacridine, N-methyl-N'-nttro-N-nitrosoguanidine, 2-2(furyl)-3-(5-nitro-2-furyl) acrylamide
- Details on test system and experimental conditions:
- The chemical was tested in a four-laboratory study by the plate-incorporation procedure without and with metabolic activation using uninduced or Aroclor 1254-induced S-9's from rats, mice, and hamsters. All plates were prepared in triplicate, and concurrent positive and negative controls were run at all times.
- Evaluation criteria:
- A positive response was defined as a dose-related increase with at least two doses being greater than, or equal to, twofold background, unless the background was less than ten, in which case a threefold increase was required. A borderline response was defined as a test in which only a single dose was equal to or greater than twofold (or threefold) background. Low-level, non-dose-related increases were scored as negative, as were single doses whose increase was the result of widely divergent replicate plate counts.
- Statistics:
- Due to study design a maximum 4 results (4 laboratories) are available without metabolic activation and 24 results with metabolic activation (4 laboratories x 3 animal species x 2 types of metabolic activation)
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- other: without metabolic activation: 1 of 4 positive, with metabolic activation: 20 of 24 positive
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- other: without metabolic activation: 1 of 4 positive, with metabolic activation: 13 of 24 positive
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- other: without metabolic activation: 0 of 3 positive, with metabolic activation: 0 of 24 positive
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- other: without metabolic activation: 1 of 4 positive, with metabolic activation: 10 of 22 positive
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- other: without metabolic activation: 1 of 4 positive, with metabolic activation: 21 of 24 positive
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- other: without metabolic activation: 0 of 4 positive, with metabolic activation: 2 of 24 positive
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive with metabolic activation
The test item is mutagenic when tested with metabolic activation in this test system. - Executive summary:
p-cresidine was tested for mutagenicity in Salmonella typhimurium strains TA98, TA100, TA1535, TA1537, and TA1538, and Escherichia coli WP2 uvrA in a four-laboratory study. The chemical was tested by the plate-incorporation procedure. The doses were ordered in half-log increments. Chemicals were tested without and with metabolic activation using uninduced and Aroclor-1254-induced S-9's from rats, mice, and hamsters. All plates were prepared in triplicate, and concurrent positive and negative controls were run at all times. The concentration did not exceed 10.0 mg/plate.
Without metabolic activation negative results were found, except one laoratory which generated positive results in all tester strains. With metabolic activation results for TA 98, 100, 1538 were predominantly positive and for TA 1535, 1537, WP2uvrA predominantly negative.
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