Benzenamine, 4-fluoro-N-(1-methylethyl)-

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics, other

Remarks:

Expert statement

Type of information:

other: The following remarks on the toxicokinetics of N-Isopropyl-4-fluoroaniline are based on the studies performed within the process of registration of a new chemical under the Chemicals Act in 2002. Experimental toxicokinetic studies were not performed.

Adequacy of study:

other information

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Objective of study:

other: Assessment of toxicokinetic behaviour

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

448-100-7

EC Name:

-

Cas Number:

70441-63-3

Molecular formula:

C9H12FN

IUPAC Name:

4-fluoro-N-(propan-2-yl)aniline

Results and discussion

Any other information on results incl. tables

Original statement:

Information/ Assumptions Regarding Toxicokinetics

 

The following remarks on the toxicokinetics of N-Isopropyl-4-fluoroaniline are based on the studies performed within the process of registration of a new chemical under the Chemicals Act. Experimental toxicokinetic studies were not performed.

 

The physical-chemical characteristics of N-Isopropyl-4-fluoroaniline (high water solubility and a molecular mass of 153.2 g/mol) are in a range suggestive of intestinal absorption subsequent to oral ingestion. The n-octanol/water partition coefficient (log Pow of 2.3) is not suggestive of accumulation of unchanged N-Isopropyl-4-fluoroaniline in fatty tissues.

 

The acute oral study (rat, LD50 of 356 mg/kg body weight, Bayer, 1993) which resulted in rapid onset of clinical signs and mortality suggests rapid enteral absorption.

N-Isopropyl-4-fluoroaniline is a liquid of low vapour pressure under normal ambient conditions. The acute inhalation study (rat, LC50 of 2580 mg/m³ air, Bayer, 1999) which resulted in rapid onset of short-lived clinical signs suggests the lungs as target organ. The signs observed were considered to be related to respiratory irritation and local pulmonary reactions were more prominent than systemic toxic effects. This indicates a limited potential for pulmonary absorption. As clinical signs had subsided within the days of exposure to high inhalative doses, one has to assume that N-Isopropyl-4-fluoroaniline is effectively eliminated by excretion and/or metabolisation. The excreta were unremarkable and did not suggest a preferred route of excretion. Molecular size and water solubility are in a range consistent with renal excretion.

 

Experiments with dermal administration (slight to moderate skin irritation, Bayer, 1994) are in line with the assumption that there is no appreciable dermal absorption. This assumption is corroborated by the result of a sensitisation study (Bayer, 1994) showing that topical challenge did not result in skin reactions and not in systemic toxic signs.

 

Because of the hydrophilicity of N-Isopropyl-4-fluoroaniline there is no reason to assume that either unchanged N-Isopropyl-4-fluoroaniline or its metabolites may accumulate in fatty tissues.