Registration Dossier

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:
2010
Bibliographic source:
International Program on Chemical Safety/Commission of the European Communities

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other:
Principles of method if other than guideline:
Details of guidelines not mentioned in the reference
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
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
Radiolabelling:
no

Test animals

Species:
other: Not applicable
Strain:
not specified
Sex:
not specified
Details on test animals 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:
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.