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Diss Factsheets
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EC number: 201-963-1 | CAS number: 90-04-0
- 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
Carcinogenicity
Administrative data
Description of key information
Carcinogenicity of o-anisidine has not been investigated. But o-anisidine hydrochloride is carcinogenic in rats and mice, with its main target organ being the urinary bladder.
Key value for chemical safety assessment
Justification for classification or non-classification
In accordance with the procedure of the EU-RAR and based on the results on carcinogenicity obtained with o-anisidine hydrochloride and the mutagenic activity of o-ansidine itself it is evident, that the submission substance has carcinogenic properties. In conclusion data are considered to be sufficient for classification as Carc 1B, H350 and Carc. Cat 2; R45 which fits to the current classification in Annex VI to Regulation (EC) No.1272/2008.
Additional information
There are no human data and no investigations in experimental animals on carcinogenicity of o-anisidine. But o-anisidine hydrochloride was found to be carcinogenic in mice and rats in a two year carcinogenicity study. The carcinogenic effect of o-anisidine hydrochloride after oral administration is probably due to o-anisidine itself, because o-anisidine hydrochloride rapidly hydrolyses to o-anisidine in vivo. In both studies the main target organ was the urinary bladder. Additionally in male rats o-anisidine hydrochloride gave rise to thyroidal tumours. The authors of the EU-RAR assume that these tumors of the thyroid "may be caused by thyroid-pituitary imbalance, leading to increases of sizeand proliferation of certain thyroid cells, in order to be able to produce enough hormone." Furthermore they concluded that o-anisidine has to be considered a genotoxic carcinogen because there is sufficient evidence that o-anisidine is mutagenic in vitro while equivocal results on genotoxicty were obtained in vivo. Additionally, an indirect mechanism cannot be ruled out for o-anisidine, since there were no indications for DNA adducts in liver and bladder of treated animals whereas an increased mutation frequency was observed in the bladder of transgenic mice.
Based on the findings mentioned above o-anisidine has been classified as carcinogenic category 2 according to Council Directive 67/548/EEC.
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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