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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Basic toxicokinetics

Currently viewing:

Administrative data

Endpoint:
basic toxicokinetics in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
publication
Title:
Metabolism of carbamate herbicides in the rat. I. Metabo1ism of M-chloroani1ine as a constituent of chlorpropham and barban.
Author:
Boehme, C. and W. Grunow.
Year:
1969
Bibliographic source:
Food Cosmet. Toxicol. 7 (2): 125-133.

Materials and methods

Objective of study:
absorption
excretion
metabolism
Principles of method if other than guideline:
Data is from Food Cosmet. Toxicol.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
3-chloroaniline
EC Number:
203-581-0
EC Name:
3-chloroaniline
Cas Number:
108-42-9
Molecular formula:
C6H6ClN
IUPAC Name:
3-chloroaniline
Details on test material:
- Name of test material (as cited in study report):3-chloroaniline
- Substance type:Organic
- Physical state:Liquid
- Impurities (identity and concentrations):NA
Radiolabelling:
no

Test animals

Species:
rat
Strain:
not specified
Sex:
male

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Erdnussol
Details on exposure:
An in-vivo study was conducted in which single 10, 60 or 150 mg/kg doses of 3-chloroaniline in Erdnussol (vehicle) were administered by gavage to male albino rats.
Duration and frequency of treatment / exposure:
24 hours
Doses / concentrations
Remarks:
Doses / Concentrations:
10, 60 or 150 mg/kg single doses
No. of animals per sex per dose / concentration:
Details not available
Control animals:
no

Results and discussion

Main ADME resultsopen allclose all
Type:
absorption
Results:
3-Chloroaniline appears to be readily absorbed orally by rats.
Type:
metabolism
Results:
Hydroxylation of the benzene ring was the primary metabolic alteration, as 2-amino-4-chlorophenol and 4-amino-2-chlorophenol and their glucuronic or sulphuric acid conjugates accounted for -16-25% and 39-50% of the administered doses, respectively.
Type:
excretion
Results:
substantial portions of single oral doses of 3-ch1oroaniline are excreted in the urine as metabolites within 24 hours. Approximately, 75% of a 10 mg/kg oral dose and 56% of a 150 mg/kg oral dose were excreted in the urine as metabolites or unchanged compd

Toxicokinetic / pharmacokinetic studies

Details on absorption:
3-Chloroaniline appears to be readily absorbed orally by rats.
Details on excretion:
Substantial portions of single oral doses of 3-ch1oroaniline are excreted in the urine as metabolites within 24 hours. Approximately, 75% of a 10 mg/kg oral dose and 56% of a 150 mg/kg oral dose were excreted in the urine as metabolites or unchanged compound within 24 hours

Metabolite characterisation studies

Metabolites identified:
yes
Details on metabolites:
2-amino-4-chlorophenol and 4-amino-2-chlorophenol and their glucuronic or sulphuric acid conjugates.

Metabolism: Hydroxylation of the benzene ring was the primary metabolic alteration, as 2-amino-4-chlorophenol and 4-amino-2-chlorophenol and their glucuronic or sulphuric acid conjugates accounted for -16-25% and 39-50% of the administered doses, respectively.
Unchanged 3-chloroaniline accounted for 0.6-1.2% of the administered doses.
Partial acetylation of the amino groups in the phenolic compounds also occurred but was not quantified.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): no bioaccumulation potential based on study results
From the data available on absorption, metabolism and excretion of 3-Chloroaniline in the present study, since the chemical was metabolized as well as rapidly excreted out of the living system in substantial proportions (depending upon the dose administered), it is concluded that 3-Chloroaniline shall have no bio-accumulation potential.
Executive summary:

From the data available on absorption, metabolism and excretion of 3-Chloroaniline in the present study, since the chemical was metabolized as well as rapidly excreted out of the living system in substantial proportions (depending upon the dose administered), it is concluded that 3-Chloroaniline shall have no bio-accumulation potential.