Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- year of publication: 2002
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Only secondary literature
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- European Union Risk Assessment Report - o-Anisidin
- Author:
- European Chemicals Bureau
- Year:
- 2 002
- Bibliographic source:
- European Commission, Joint Research Center, EUR 19834 EN, 2nd Priority list, Volume 15
Materials and methods
Test material
- Reference substance name:
- o-anisidine
- EC Number:
- 201-963-1
- EC Name:
- o-anisidine
- Cas Number:
- 90-04-0
- Molecular formula:
- C7H9NO
- IUPAC Name:
- 2-methoxyaniline
Constituent 1
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- From toxicological studies the absorption via the dermal, oral and inhalation pathways are assumed.
- Details on excretion:
- The substance is excreted fast (>90% within 96h; majority in the first 24 h) mainly in the urine.
Any other information on results incl. tables
Oral, dermal and resorption after inhalational exposure can be assumed as systemic effects were observed in toxicological studies. Metabolism seems to be comparable to other aromatic amines: N-hydroxylation and N- or O-acetylation take place as well as peroxidation occurs via enzymes like prostaglandin-H-synthase. Furthermore, O-demethylation may appear.
These different metabolism pathways mentioned are supported by findings in diverse studies and some conclusions can be drawn. For example one could assume that the N-hydroxy derivative, maybe responsible for the formation of methaemoglobin due to the known interaction of this group with the haem group of hemoglobin. Or the activation of o-anisidine by N-/O-acetylation can be confirmed by positive mutagenic response in bacterial gene mutation assays with Salmonella typhimurium strains containing elevated levels of N- or O-acetyltransferase levels. There are in vitro studies showing that horseradish peroxidase (used as model enzyme) induces the formation of reactive intermediates of o-anisidine. This is also suggested to be true for prostaglandin-H synthase, which is broadly distributed in mammalian tissues including the urinary bladder. Incubation of o-anisidine with the thyroid peroxidase, its endogenous subtrates guiacol and iodide as well as H2O2, the transformation of guiacol and iodide was efficiently inhibited (IC50: 1.9 µM). in another in vitro study O-demethylation occurred using microsomes from rat liver (relative rate of o-anisidine as compared to the formation of formaldehyde from N,N-dimethylaniline: 13%).
The major excretion pathway was identified in another toxicokinetic study (OECD Guideline 417) using a dye containing radioactive carbon. The study summarieses as follows: "..., the dye14C-FAT 923 67/A was orally administered to Wistar rats (single oral administration at a target dose level of 7.4 mg/kg bw). Probably as a result of the bacterial breakdown of this compound in the gastrointestinal tract,o-anisidine could be detected in the plasma of male rats (1.5% of the administered14C-activity characterised as o-anisidine [0.017 µg/g]), in the urine of male rats (0.14% of the administered 14C-activity) and in faeces of male and female rats (0.9 or 1.1% of the administered14C-activity,resp.). Within 96 hours more than 93% of the administered 14C-activity were excreted mainly via urine; the major amount was excreted within the first 24 hours."
Applicant's summary and conclusion
- Conclusions:
- Oral, dermal and resorption after inhalational exposure can be assumed as systemic effects were observed in toxicological studies.
Metabolism seems to be comparable to other aromatic amines: N-hydroxylation and N- or O-acetylation take place as well as peroxidation occurs via enzymes like prostaglandin-H-synthase (note: o-anisidine is also a substrate of thyroid peroxidase). Furthermore, O-demethylation may appear. The urine is proved to be the main exretion route, as >90% of the applied 14C-activity was excreted within 96 h in rats in one toxicokinetic study.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.