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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Additional information
There are no studies available on reproductive toxicity for o-anisidine.
Observations of histopathological examinations of the NCI (1978) two year carcinogenicity study (test item: o-anisidine hydrochloride) with mice and rats showed no effects on the male and female reproductive organs (examinations included: seminal vesicles, prostate, and testis in males; ovary and uterus in females).
In a 28 day repeated dose toxicity study (test item: o-anisidine; oral application) with male and female rats no effects on the testes were seen (female organs were not examined).
The EU-RAR concluded that these data do not indicate that o-anisidine impairs reproduction.
Short description of key information:
There are no information on toxicity of o-anisidine to reproduction. Data on related substances indicate that o-anisidine does not impair fertility.
Effects on developmental toxicity
Description of key information
There are no information on developmental toxicity of o-anisidine. The EU-RAR concluded that due to positive evidence from related substances, "o-anisidine may be suspected to possess teratogenic properties."
Additional information
There are no information on developmental toxicity of o-anisidine. Data on developmental toxicity and teratogenicity of structurally related substances to o-anisidine are discussed in the EU-RAR:
o-Aminophenol, a known metabolite of o-anisidine, revealed embryotoxic and teratogenic properties investigated in the syrian hamster (i.p.application of 100 mg/kg bw; no maternal toxicity was observed at this dose).
p-Aminophenol, a structurally less related substance, showed clearly teratogenic and developmental toxic effects. For example in several studies after oral application in rats (no statements given whether there was maternal toxicity observed) as well as in hamster after i.p. or i.v. application in the absence of toxicity to the dams.
There is also evidence for developmental toxicity and teratogenicity of aniline.
In the RAR it is concluded that the effects from aniline can be compared to the expected effects for o-anisidine as both substances cause methaemoglobinemia. The methaemoglobin formation observed in animals treated with aromatic amines in general may affect the developing organisms of the offsprings even more than the dams. Genotoxicity may also be responsible for the damaging effects in early stages of the developing offspring (both o- and p-aminophenol are classified as Cat. 3 mutagens). But the evidence for genotoxic potential of o-anisidine from the in vivo genotoxicity tests is not convincing.
Justification for classification or non-classification
There are no data on reproductive toxicity of o-anisidine available. The EU-RAR concluded that existing data on related substances indicate that o-anisidine does not impair fertility but may be suspected to posses teratogenic properties. However, a final conclusion on classification of o-anisidine for toxicity to reproduction cannot be drawn from these data.
Additional information
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.