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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
basic toxicokinetics in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1986
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Abstract only

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1986

Materials and methods

Objective of study:
metabolism
Test guideline
Qualifier:
no guideline followed
Deviations:
not applicable
Principles of method if other than guideline:
The study was designed to investigate the urinary metabolites of 2,4-Xylidine in the dog and rat. Male Beagles were orally dosed for one or 10 days with 2,4-Dimethylaniline at 25 mg/kg bw. Male Fischer 344 rats were gavaged with 2,4-Dimethylaniline at 25 % of their respective LD50 (117 mg/kg) for the same time periode. 24 h urine samples were analysed by GC and GC/MS.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
2,4-xylidine
EC Number:
202-440-0
EC Name:
2,4-xylidine
Cas Number:
95-68-1
Molecular formula:
C8H11N
IUPAC Name:
2,4-dimethylaniline
Details on test material:
no data
Radiolabelling:
no

Test animals

Species:
other: rat and dog
Strain:
other: Fischer 344 and Beagle
Sex:
male
Details on test animals or test system and environmental conditions:
no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on exposure:
no data
Duration and frequency of treatment / exposure:
1 and 10 days
Doses / concentrations
Remarks:
Doses / Concentrations:
25 mg/kg bw/d (Dog)
117 mg/kg bw/d (Rat)
No. of animals per sex per dose / concentration:
no data
Control animals:
not specified
Positive control reference chemical:
no data
Details on study design:
Male Beagles were orally dosed for one or 10 days with 2,4-Dimethylaniline at 25 mg/kg bw/d. Male Fischer 344 rats were gavaged with 2,4-Dimethylaniline at 117 mg/kg bw/d (25 % of their respective LD50) for the same time period. 24 h urine samples were analysed by GC and GC/MS.
Details on dosing and sampling:
no data
Statistics:
no data

Results and discussion

Main ADME results
Type:
metabolism
Results:
Major metabolite: 6-Hydroxy-2,4-dimethylaniline (dog); N-Acetyl-4-Amino-3-Methyl-Benzoic acid (rat)

Toxicokinetic / pharmacokinetic studies

Details on absorption:
n.a., metabolism study
Details on distribution in tissues:
n.a., metabolism study
Details on excretion:
The major urinary metabolite of the test item in the dog was 6-Hydroxy-2,4-dimethylaniline. Minor metabolites included 4-Amino-3-methyl-benzoic acid and N,2,4-Trimethylaniline. Rats produced N-Acetyl-4-Amino-3-Methyl-Benzoic acid as the major metabolite and N,2,6-Trimethylaniline in small amounts.

Metabolite characterisation studies

Metabolites identified:
yes
Details on metabolites:
Dog:
- 6-Hydroxy-2,4-dimethylaniline
- 4-Amino-3-methyl-benzoic acid
- N,2,4-Trimethylaniline

Rat:
- N-Acetyl-4-Amino-3-Methyl-Benzoic acid
- N,2,6-Trimethylaniline

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): no data
The major urinary metabolite of the test item in the dog was 6-Hydroxy-2,4-dimethylaniline. Minor metabolites included 4-Amino-3-methyl-benzoic acid and N,2,4-Trimethylaniline. Rats produced N-Acetyl-4-Amino-3-Methyl-Benzoic acid as the major metabolite and N,2,6-Trimethylaniline in small amounts.
Executive summary:

Please refer to "Conclusions"