Registration Dossier
Registration Dossier
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EC number: 203-254-2 | CAS number: 104-94-9
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- other: Information collated from various credible sources as well as considering the physico-chemical properties of p-anisidine in a weight of evidence approach.
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The reference is an authoritative source of information
Data source
Reference
- Reference Type:
- secondary source
- Title:
- International Chemical Safety Card on p-Anisidine (April 1999). Available from, as of May 20, 2010
- Author:
- WHO, ILO, and the UNEP
- Year:
- 2 010
- Bibliographic source:
- International Program on Chemical Safety/Commission of the European Communities
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- Details of guidelines not mentioned in the reference
- GLP compliance:
- not specified
Test material
- Reference substance name:
- p-anisidine
- EC Number:
- 203-254-2
- EC Name:
- p-anisidine
- Cas Number:
- 104-94-9
- Molecular formula:
- C7H9NO
- IUPAC Name:
- 4-methoxyaniline
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- CAS No: 104-94-9
Chemical Name: p-anisidine
Nature of chemical: Organic
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- other: Not applicable
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No data
Administration / exposure
- Route of administration:
- other: no route specified, but chemical is known to be absorbed by the oral, dermal and inhalation route
- Vehicle:
- not specified
- Duration and frequency of treatment / exposure:
- No data
Doses / concentrations
- Remarks:
- Doses / Concentrations:
No data
- No. of animals per sex per dose / concentration:
- No data
- Control animals:
- not specified
Results and discussion
Main ADME resultsopen allclose all
- Type:
- absorption
- Results:
- The test substance can be absorbed into the body by inhalation of its vapor, through the skin and by ingestion.
- Type:
- distribution
- Results:
- Given the high water solubility of the chemical (approx. 21000 mg/L at 20 deg C), it is expected that the chemical shall be transported via blood to other parts of the body.
- Type:
- metabolism
- Results:
- Metabolism: Most of the metabolism of chemicals/drugs in living organisms is reported to take place in the liver.
- Type:
- excretion
- Results:
- No information about the excretion of the chemical is available.
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- p-aminophenol &
p-methoxy-n-methylaniline
Any other information on results incl. tables
The predicted bio-concentration factor (BCF) for p-anisidine using the EPI Suite model is 3.16 L/kg wet-wt. This value suggests, low bio-accumulation potential.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): other: Bio-accumulation potential cannot be judged based on the available information.
The test substance p-anisidine can be absorbed into the body by inhalation of its vapor, through the skin and by ingestion. Considering the high water solubility and low partition co-efficient values, the chemical after absorption shall be bio-available for metabolism. However, since no information is available on the absorption, distribution, metabolism and excretion of p-anisidine in humans, bio-accumulation potential cannot be judged based on the available information. - Executive summary:
The test substance p-anisidine can be absorbed into the body by inhalation of its vapor, through the skin and by ingestion.This chemical also has a harmonized classification for acute oral, inhalation and dermal toxicity. Considering the high water solubility and low partition co-efficient values, the chemical after absorption shall be bio-available for metabolism. There is no information on the metabolites formed in humans; though in rabbits it is suggested that p-aminophenol & p-methoxy-n-methylaniline are formed. Reports also suggest that it leads to blood damage in living organisms.
However, since no information is available on the absorption, distribution, metabolism and excretion of p-anisidine in humans, bio-accumulation potential cannot be judged based on the available information.
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