Registration Dossier
Registration Dossier
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EC number: 939-509-6 | CAS number: -
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No OECD guideline or GLP defined.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 009
Materials and methods
- Objective of study:
- other: Identification of an N-acetylcysteine conjugate in the urine after oral administration of 2,4-dichloro-1-nitrobenzene to rats
- Principles of method if other than guideline:
- other: Identification of an N-acetylcysteine conjugate in the urine after oral administration of 2,4-dichloro-1-nitrobenzene to rats
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 1,3-dichloro-4-nitrobenzene
- EC Number:
- 210-248-3
- EC Name:
- 1,3-dichloro-4-nitrobenzene
- Cas Number:
- 611-06-3
- Molecular formula:
- C6H3Cl2NO2
- IUPAC Name:
- 2,4-dichloro-1-nitrobenzene
- Details on test material:
- no data
Constituent 1
- Radiolabelling:
- yes
Test animals
- Species:
- rat
- Strain:
- Fischer 344/DuCrj
- Sex:
- male
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: Test substance mixed into CRF-1 powdered diet.
- Duration and frequency of treatment / exposure:
- rats were fed the diet containing the test substance for 2 days.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
diet containing 1.0% test substance
- No. of animals per sex per dose / concentration:
- 3
- Control animals:
- yes
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- see: executive summary
- Details on distribution in tissues:
- see: executive summary
Transfer into organs
- Observation:
- other: see: executive summary
- Details on excretion:
- see: executive summary
Toxicokinetic parameters
- Toxicokinetic parameters:
- other: see: executive summary
Any other information on results incl. tables
see: executive summary
Applicant's summary and conclusion
- Executive summary:
In an oral study in male F344/DuCrj rats, the animals received diet containing 1.0% test substance for 3 days.
The objective of this study was to identify the chemical structure of the test substance metabilites in urine. Urine from the test substance fed rats was more yellow than urine from control rats, exhibiting a broad UV-spectrum around a peak wavelength of 360 nm; the control urine did not have an absorbance. The yellow component was extracted and analyzed. The optical properties of the yellow component were the same as the N-acetylcysteine conjugate of 1,4 -dichloro-2 -nitrobenzene: 1,4 -DCNB is secreted in urine as an N-acetylcysteine conjugate. LC-MS/MS analyses of this yellow component demonstrated its chemical structure to be the N-acetylcysteine conjugate of the test substance. Nuclear overhauser effect and LC-MS/MS analyses revealed the structural isomer of this test substance metabolite as N-acetyl-S-(5 -chloro-2 -nitrophenyl)-L-cysteine.
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