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EC number: 202-429-0 | CAS number: 95-53-4
- 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
Additional information
There are several publications available in which the test of o-toluidine respective its hydrochloride for gene mutations in bacteria (Ames test, OECD TG 471) are reported. The following species and strains were used: Salmonella typhimurium TA 98, TA100, TA1535, TA1537, TA102, TA104, and Escherichia coli WP2urA, WP2urA/pKM101 without S9-mix and with S9-mix prepared from hamster or rat livers (e.g. JETOC 1997, Rexroat 1985, Zeiger 1985 und 1992). o-Toluidine did not reveal mutagenic activity neither with nor without a metabolic activation system, except in S typh TA 100 in the presence of 30% S9-mix prepared from hamster liver. Regarding gene mutation tests in mammalian cell systems (HPRT, MLA; e.g. Kuroda 1985, Fox 1985, Myhr 1985, Amacher 1985) the available results are inconsistent: Kuroda and Myhr observed mutagenic activity in the HPRT- resp MLA-test in the absence of a metabolic activation system whereas Fox and Amacher evaluated o-toluidine as non-mutagenic in the HPRT- resp MLA- test in both, with and without an activation system.
o-toluidine was also tested for its ability to induce chromosomal aberrations in Chinese hamster ovary cells in vitro (Gulati 1985) and in an in vitro MNT test in human lymphocytes (Vian 1993), both in the presence and in the absence of a metabolic activation system. o-Toluidine showed clear clastogenic activity in vitro in both protocols. However, regarding the in vivo tests for clastogenic activity these results cannot be confirmed as seen in the publications e.g. of NcFee 1989 and Nakai 1994 in which negative results in an in vivo MNT and in vivo Chromosome aberration tests are reported.
Thus, the described in vitro and in vivo tests show the genotoxicity test results typical for the class of aromatic amines. o-Toluidine shows positive and negative results in point mutation assays and clear clastogenic activity in vitro which could not be confirmed by the respective in vivo tests. This evaluation is in line with the evaluation of the OECD /SIDS of o-toluidine, published by UNEP in 2006.
Justification for selection of genetic toxicity endpoint
No special test is selected because there are reliable publications reporting valid studies for all three types of in-vitro mutagenicity tests as required by REACH : Mutagenicity tests in bacteria and in mammalian cell systems and chromosome aberration tests in mammalian cell systems. All these tests are therfore evaluated with Klimisch Score 2. However, there are positive and negative results in each test system reflecting the typical situation with aromatic amines.
Short description of key information:
The described in vitro and in vivo tests show the genotoxicity test results typical for the class of aromatic amines. o-Toluidine shows positive and negative results in point mutation assays and clear clastogenic activity in vitro which could not be confirmed by the respective in vivo tests. This evaluation is in line with the evaluation of the OECD /SIDS of o-toluidine, published by UNEP in 2006
Endpoint Conclusion: Adverse effect observed (positive)
Justification for classification or non-classification
the described in vitro and in vivo testsshow the genotocicity test results typical for the class of aromatic amines o-Toluidine itself was tested positive for mutagenicity in an in vitro mammalian cell gene mutation assay with L5178Y (TK+/TK-) mouse lymphoma cells. o-Toluidine showed positive results tests with mammalian cell systems (HPRT, micronucleus in lymphocyte, chromosome aberration).
Therefore it is suggested to classify o-toluidine as Category 3 (DSD-DPD) and Category 2 (GHS) Mutagen.
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