Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Additional information:
From study record RAR:
In a very doubtful guinea pig test o-anisidine revealed a weak sensitisation potential (intra- and epicutaneous application of 0.5 or 2.5 mg/kg bw resp.; no further information available). In a local lymph node assay using a standard test protocol a dose related unequivocal positive response for o-aminophenol was found (o-aminophenol can be formed in the metabolism of o-anisidine as was shown in in vitro studies).This metabolite of o-anisidine also gave a positive result in a modified single injection adjuvant test. However, one valid and well-documented guinea pig maximization test on a structural related compound o-phenetidine (1 -amino-2 -ethoxy-benzene) showed negative test results. In their overall evaluation the authors of the RAR state that "uncertainty remains as to whether or not o-anisidine possesses skin sensitizing potential and further information would be required to resolve this issue."
Latest data:
A subsequent recently finalized LLNA (OECD 429, reliability 1) revealed no clear results as well. Based on S.I. values one of which is slightly above 3, o-Anisidine would formally have to be regarded as a skin sensitiser. But due to missing dose response relationship, potentially irritating effects, and the impairment by an unexplained death of one animal this interpretation seems not to be entirely reliable. Thus the final conclusion is that the outcome of this study is considered to be equivocal.
Migrated from Short description of key information:
Available data are equivocal and do not allow a final conclusion on skin sensitizing properties.
Justification for classification or non-classification
Skin sensitization:
Based on the equivocal data available which allow no final conclusion and in view of the existing classification which guaranties a high protection level an additional classification as skin sensitizer seems dispensable.
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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