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EC number: 203-583-1 | CAS number: 108-44-1
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Short description of key information:
There is an Ames test performed according to OECD TG 471 and yielded
a negative result (MHLW 2002). An HPRT test was performed with
m-toluidine according to the respective guideline and yielded a negative
result (WOLLNY 2014).
There is an in-vitro Chromosome Aberration test with CHL/IU cells
performed according to OECD TG 473 and yielded a negative result (MHLW
1995)
Endpoint Conclusion: No adverse effect observed (negative)
Link to relevant study records
- 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:
- other: Guideline study and GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Principles of method if other than guideline:
- Procedure: plate incorporation method.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- other: Salmonella typhimurium TA 100, TA1535, TA98, TA1537, Eschericha coli WP2uvrA
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver induced with phenobarbital and 5,6-benzoflavone
- Test concentrations with justification for top dose:
- +/- S9-mix: 0, 313, 625, 1250, 2500, 5000 µg/plate
- Vehicle / solvent:
- dimethyl sulfoxide
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide, sodium azide, 9-aminoacridine, 2-aminoanthracene
- Details on test system and experimental conditions:
- preincubation methodology
- Evaluation criteria:
- positive when assay plates with the test substance show a significant increase in revertantcolony count as compared with that on negative control plates and when this effect is reasonably reproducible or dosedependent
- Statistics:
- yes, but method not mentioned
- Species / strain:
- other: Salmonella typhimurium TA 100, TA1535, TA98, TA1537, Eschericha coli WP2uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- m-Toluidine was not mutagenic in Salmonella typhimurium TA 100, TA1535, TA98, TA1537, Eschericha coli WP2uvrA with and without an exogenous metabolic activation system.
- Remarks on result:
- other: other: Salmonella typhimurium TA 100, TA1535, TA98, TA1537, Eschericha coli WP2uvrA
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Negative in TA 100, TA1535, TA98, TA1537, Eschericha coli WP2uvrA with and without an exogenous metabolic activation system.
- Executive summary:
Genotoxicity of m-toluidine was studied by a Reverse Mutation test in bacteria (Ames test) according to OECD TG 471 and GLP. m-Toluidine was not mutagenic in Salmonella typhimurium TA 100, TA1535, TA98, TA1537, Eschericha coli WP2uvrA with and without an exogenous metabolic activation system (MHLW 2002).
- 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
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- GLP compliance:
- yes
- Type of assay:
- mammalian cell gene mutation assay
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- - Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: yes - Additional strain / cell type characteristics:
- other: Chinese hamster lung fibroblasts (V79): the cells have a stable karyotype with a modal chromosome number of 22
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital/ß-naphthoflavone induced rat liver S9-mix
- Test concentrations with justification for top dose:
- Pretest on toxicity
4 h in the presence and 4 and 24 h in the absence of a metabolic activation system:
8.4 µg - 1072 µg/ml (approximately equal to 10mM)
GENE MUTATION ASSAY
--EXPERIMENT I
4 h without S9 mix:
67.0, 134.0, 268.0, 536.0, 1072 µg/ml
4 h with S9 mix:
67.0, 134.0, 268.0, 536.0, 1072 µg/ml
--EXPERIMENT II
24 h without S9 mix:
134.0, 268.0, 536.0, 804.0, 1072 µg/ml
4 h with S9 mix:
67.0, 134.0, 268.0, 536.0, 1072 µg/ml - Vehicle / solvent:
- Ethanol
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 7,12-dimethylbenzanthracene
- ethylmethanesulphonate
- Details on test system and experimental conditions:
- The assay was performed in 2 independent experiments, using 2 parallel cultures each. The first main experiment was performed with and without liver microsomal activation and a treatment period of 4 hours. The second experiment was performed with a treatment time of 4 hours with and 24 hours without metabolic activation
- Evaluation criteria:
- A test item is classified as positive if it induces either a concentration-related increase of the mutant frequency or a reproducible and positive response at one of the test points that is three times above the spontaneous mutation frequency.
A test item producing neither a concentration-related increase of the mutant frequency nor a reproducible positive response at any of the test points is considered non-mutagenic in this system. - Statistics:
- A linear regression (least squares) was performed to assess a possible dose dependent increase of mutant frequencies. The number of mutant colonies obtained for the groups treated with the test item were compared to the solvent control groups. A trend is judged as significant whenever the p-value (probability value) is below 0.05.
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Relevant cytotoxic effects indicated by a relative cloning efficientcy 1 or cell density below 50% occurred only in the absence of metabolic activation at 1072 µg/ml in experiment 1 (4 hr treatment) and experiment 2 (24 hr treatment)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- the positive controls were functional
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results: negative
- Executive summary:
The study was performed to investigate the potential of m-toluidine to induce gene mutations at the HPRT locus in V79 cells of the Chinese hamster according to OECD TG 476 under GLP conditiions. The assay was performed in two independent experiments, using two parallel cultures each. The first main experiment was performed with and without liver microsomal activation and a treatment period of 4 hours (33.5 µg/ml - 1072 µg/ml). The second experiment was performed with a treatment time of 4 hours with (33.5 µg/ml - 1072µg/ml) and 24 hours without (67.0 µg/ml -1072 µg/ml) metabolic activation. Relevant cytotoxic effects indicated by a relative cloning efficientcy 1 or cell density below 50% occurred only in the absence of metabolic activation at 1072 µg/ml in experiment 1 (4 hr treatment) and experiment 2 (24 hr treatment).
No relevant and reproducible dose dependent increase in mutation frequency was observed in both main experiments. Appropriate reference mutagens, used as positive controls, induced a distinct increase in mutant colonies and thus, showed the sensitivity of the test system and the activity of the metabolic activation system.
In conclusion, it can be stated that under the experimental conditions reported the test item did not induce gene mutations at the HPRT locus in V79 cells. Therefore, m-toluidine is considered to be non-mutagenic in this HPRT assay.
- Endpoint:
- in vitro cytogenicity / chromosome aberration 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
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- Chinese hamster CLHL/IU cells
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver induced with phenobarbital and 5,6-benzoflavone
- Test concentrations with justification for top dose:
- -S9-mix: 0, 0.13, 0.26, 0.52 mg/ml (continuous treatment)
-S9-mix: 0, 0.3, 0.6, 1.1 mg/ml (short-term treatment)
+S9-mix: 0, 0.3, 0.6, 1.1 mg/ml (short-term treatment) - Vehicle / solvent:
- DMSO
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: -S9-mix: Mitomycin C; +S9-mix: Cyclophosphamide
- Details on test system and experimental conditions:
- as requested by the guideline
- Evaluation criteria:
- the test substance is considered positive when assay cultures with the test substance show a significantly higher incidence of cells with chromosome aberrations as compared with the negative controls and when this effect is reasonably reproducible or dose-dependent
- Statistics:
- yes, according to Ishidate, 1987
- Species / strain:
- other: Chinese hamster Lung /IUL cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- -S9-mix: >0.52 mg/ml (continuous treatment); -S9-mix: >1.1 mg/ml (short-term treatment); + S9-mix: >1.1 mg/ml (short-term treatment)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results: negative
- Executive summary:
m-Toluidine was tested for clastogenic activity in a chromosome aberration test in Chinese hamster CHL/IUL cells according to OECD TG 473 under GLP conditions in the presence and in the absence of a metabolic activation system. No mutagenic activity of m-toluidine was detected. The concurrent substances used as positive controls were functional. Thus, m-toluidine has no clastogenic property.
Referenceopen allclose all
m-Toluidine was not mutagenic in Salmonella typhimurium TA 100, TA1535, TA98, TA1537, Eschericha coli WP2uvrA with and without an exogenous metabolic activation system.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
No valid in vivo genotoxicity test available.
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Genotoxicity of m-toluidine was studied by a Reverse Mutation test in bascteria (Ames test) according to OECD TG 471 and GLP. m-Toluidine showed no mutagenic activity in Salmonella typhimurium TA 100, TA1535, TA98, TA1537, Eschericha coli WP2uvrA with and without an exogenous metabolic activation system. Appropriate positive control substances were functional (MHLW 2002)
A study was performed to investigate the potential of m-toluidine to induce gene mutations at the HPRT locus in V79 cells of the Chinese hamster according to OECD TG 476 under GLP conditiions. The assay was performed in two independent experiments, using two parallel cultures each. The first main experiment was performed with and without liver microsomal activation and a treatment period of 4 hours (33.5 µg/ml - 1072 µg/ml). The second experiment was performed with a treatment time of 4 hours with (33.5 µg/ml - 1072µg/ml) and 24 hours without (67.0 µg/ml -1072 µg/ml) metabolic activation. Relevant cytotoxic effects indicated by a relative cloning efficientcy 1 or cell density below 50% occurred only in the absence of metabolic activation at 1072 µg/ml in experiment 1 (4 hr treatment) and experiment 2 (24 hr treatment).
No relevant and reproducible dose dependent increase in mutation frequency was observed in both main experiments. Appropriate reference mutagens, used as positive controls, induced a distinct increase in mutant colonies and thus, showed the sensitivity of the test system and the activity of the metabolic activation system.
In conclusion, it can be stated that under the experimental conditions reported the test item did not induce gene mutations at the HPRT locus in V79 cells. Therefore, m-toluidine is considered to be non-mutagenic in this HPRT assay.
m-Toluidine was tested for clastogenic activity in a chromosome aberration test in Chinese hamster CHL/IUL cells according to OECD TG 473 under GLP conditions in the presence and in the absence of a metabolic activation system. No mutagenic activity of m-toluidine was detected. The concurrent substances used as positive controls were functional. Thus, m-toluidine has no clastogenic property.
OVERALL m-Toluidine was tested for mutagenicity using point mutation
tests in bacteria and in mammalian cells as well as a test for chromosme
aberrations. All tests were performed according to the respective
guidelines under GLP conditions. No mutagenic activity was detected.
Thus, it can be concluded that m-toluidine is a non-mutagenic substance
Short description of key information:
There is an Ames test performed according to OECD TG 471 and yielded
a negative result (MHLW 2002). An HPRT test was performed with
m-toluidine according to the respective guideline and yielded a negative
result (WOLLNY 2014).
There is an in-vitro Chromosome Aberration test with CHL/IU cells
performed according to OECD TG 473 and yielded a negative result (MHLW
1995)
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
All relevant in-vitro tests (key studies) are negative.
According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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