Registration Dossier
Registration Dossier
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EC number: 201-923-3 | CAS number: 89-61-2
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
Data source
Reference
- Reference Type:
- publication
- Title:
- Characterization of N-Acetylcysteine conjugate in yellow urine by oral administration of 1,4-Dichloro-2-Nitrobenzene
- Author:
- Makoto Ohnishi,a Kazunori Yamazaki, Seigo Yamamoto, and Taijiro Matsushima
- Year:
- 2 004
- Bibliographic source:
- Journal of health science, 50 (3) 319-322 (2004)
Materials and methods
- Objective of study:
- metabolism
- Principles of method if other than guideline:
- In Vivo Metabolism of 1,4-Dichloro-2-Nitrobenzene in F344/DuCrj male rats
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 1,4-dichloro-2-nitrobenzene
- EC Number:
- 201-923-3
- EC Name:
- 1,4-dichloro-2-nitrobenzene
- Cas Number:
- 89-61-2
- Molecular formula:
- C6H3Cl2NO2
- IUPAC Name:
- 1,4-dichloro-2-nitrobenzene
- Details on test material:
- - Name of test material (as cited in study report): 1,4-Dichloro-2-Nitrobenzene
- Molecular formula (if other than submission substance): C6-H3-Cl2-N-O2
- Molecular weight (if other than submission substance): 192.001 g/mole
- Substance type: Organic
- Physical state: No data available
- Impurities (identity and concentrations): No data available
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344/DuCrj
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles river Japan, Inc. (Atsugi, Japan)
- Age at study initiation: No data available
- Weight at study initiation: No data available
- Fasting period before study: No data available
- Housing: Animals were housed in polycarbonate metabolic cages.
- Diet (e.g. ad libitum): CRF-1 powdered diet, ad libitum
- Water (e.g. ad libitum): No data available
- Acclimation period: No data available
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23± 1°C
- Humidity (%): 58 ±8 %
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available
IN-LIFE DATES: From: To: No data available
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: CRF-1 powdered diet
- Details on exposure:
- Doses were administrated by mixing 1,4-Dichloro-2-Nitrobenzene into CRF-1 powdered diet
- Duration and frequency of treatment / exposure:
- 2 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1.0 %
- No. of animals per sex per dose / concentration:
- Total : 6
0 %: 3 male
1.0 %: 3 male - Control animals:
- yes, concurrent vehicle
- Positive control reference chemical:
- No data available
- Details on study design:
- No data available
- Details on dosing and sampling:
- No data available
- Statistics:
- No data available
Results and discussion
- Preliminary studies:
- No data available
Main ADME resultsopen allclose all
- Type:
- absorption
- Results:
- No data available
- Type:
- distribution
- Results:
- No data available
- Type:
- metabolism
- Results:
- N-acetylcysteine and N-acetyl-S-(4-chloro-3-nitrophyenyl)-L-cysteine conjugates were from
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- No data available
- Details on distribution in tissues:
- No data available
- Details on excretion:
- No data available
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- Metabolisum of 1,4-Dichloro-2-Nitrobenzene resulting in the formation of N-acetylcysteine and N-acetyl-S-(4-chloro-3-nitrophyenyl)-L-cysteine conjugates from glutathione conjugates.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): low bioaccumulation potential based on study results
1,4-Dichloro-2-Nitrobenzene expected to have Low bio-accumulation potential based on study results. - Executive summary:
In a vivoToxico-kinetics study, F344/DuCrj male rats were treated with 1,4-Dichloro-2-Nitrobenzene in the concentration of 1.0 % orally in diet. Urine samples were collected after 24 hr in metabolic cage and analyzed by usingUV,IH-NMR and LC-MS/MS analyses. Metabolisum of 1,4-Dichloro-2-Nitrobenzene resulting in the formation of N-acetylcysteine and N-acetyl-S-(4-chloro-3-nitrophyenyl)-L-cysteine conjugates from glutathione conjugates detected by LC-MS/MS analyses. Therefore, On the basis of given result1,4-Dichloro-2-Nitrobenzene expected to have Low bio-accumulation potential based on study results.
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