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Diss Factsheets
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EC number: 216-032-5 | CAS number: 1477-55-0
- 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
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Carcinogenicity
Administrative data
Description of key information
Based on available repeated dose toxicity and genotoxicity studies, as well as two independent QSAR methods, m-phenylene-bis(methylamine) is not expected to be carcinogenic.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Justification for classification or non-classification
Based on the evaluation of all available studies on repeated dose toxicity and genotoxicity of m-phenylene-bis(methylamine) as well as predictions by two independent QSAR methods, there are no indications of potential carcinogenicity of the substance. Respectively, classification of m-phenylene-bis(methylamine) for carcinogenicity is considered to be not warranted.
Additional information
Potential carcinogenic properties of m-phenylene-bis(methylamine) have been evaluated using all available repeated dose toxicity and genotoxicity studies with the substance and the predictions of two independent QSAR software packages, DEREK Nexus v.4.1.0 and Toxtree v.2.6.13, based on the substance structural properties.
The substance gave negative results in all available in vitro and in vivo genotoxicity tests and is thus not expected to be genotoxic. Available genotoxicity studies fulfil the data requirements under REACH Annex X and no further genotoxicity studies are warranted at the moment. In the available 90-day inhalation toxicity study with rats, local effects in the respiratory tract were observed, including bronchial epithelium degeneration and subacute inflammation in the lungs, which are considered to be caused by the corrosive nature of the substance. This is consistent with the fact that the observed local effects were not accompanied by any systemic effects or macroscopic changes, and that the observed histopathological changes were reversible in nature and not observed after a recovery period of 27 days. The observed local effects were also consistent with the results of the in vivo skin corrosion test, indicating the substance to be corrosive, and local effects at the port of entry (stomach) in the available reproductive and developmental screening study, in which the substance was administered in water by gavage. The only systemic effect which could potentially be regarded as a precursor of neoplastic lesions, was a diffuse hyperplasia of adrenal cortex observed in the available reproductive/developmental screening study. However, based on the available genotoxicity data, the substance is not a genotoxic carcinogen, which means, that even if it is indeed able to induce neoplastic lesions in long-term studies, a threshold level would exist for such effects, below which they would not occur. As the derived NOAELs in the reproductive/screening toxicity studies take the observed hyperplasia of adrenal cortex into account, potential carcinogenic effects are considered to be covered in the risk assessment. It should also be noted that the observed systemic effects were seen only following the test substance administration by oral route, and not by inhalation route, as was confirmed by the results of the available 90 -day inhalation toxicity study.
Potential carcinogenic and genotoxic properties of m-phenylene-bis(methylamine) have also been predicted using DEREK Nexus v.4.1.0 and Toxtree v.2.6.13 software. Neither of the used QSAR methods indicated the presence of structural alerts for either genotoxic or non-genotoxic carcinogenicity based on the structure of the substance. Respectively, the substance was predicted to be not carcinogenic.
In summary, based on all available data, there are no indications of potential carcinogenicity of m-phenylene-bis(methylamine). The performance of additional carcinogenicity studies with this substance is therefore considered to be not warranted.
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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