Registration Dossier
Registration Dossier
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EC number: 401-540-3 | CAS number: 84632-65-5
Basic toxicokinetics
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:
- other: Body responsible for the test
- Title:
- Unnamed
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: 88/302/EEC PART B
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 401-540-3
- EC Name:
- -
- Cas Number:
- 84632-65-5
- Molecular formula:
- C18H10Cl2N2O2
- IUPAC Name:
- 3,6-bis(4-chlorophenyl)-1H,2H,4H,5H-pyrrolo[3,4-c]pyrrole-1,4-dione
- Details on test material:
- Details of label:
The labeling was achieved by C-14 in both carbons which belong to both pyrrol-rings.
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- C-14
Test animals
- Species:
- rat
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: suspension in 0.5% CMC in 0.9% NaCl
- No. of animals per sex per dose / concentration:
- Male: 5 animals at 100 mg/kg
Male: 5 animals at 1000 mg/kg
Results and discussion
Any other information on results incl. tables
The animals were killed 168 h p.a.. During the 168 h 0.3 resp. 0.6% of the applied redioactivity was found in the urine. These small amounts are interpreted as technic-related faecalic impurities.
The pare which was incorporated in the faeces were in average 119.7% (low dose group) rsp. 96.0%. The corresponding fraction after 24h was 101.4% rsp. 79.7%. In both dosage groups only neglictible amounts of the radioactive substance were detected in the organs and the tissue, in the intestinal tract, in the blood and in the carcasse. The maximal concentration in the blood was 0.139 ag/g (low dosage group) rsp. 1.152 ag/g and in the plasma 0.140 rsp. 1.048 ag/g. The maxima were reached 1 to 2 h after application. As the concentration is close to the detection limit the kinetics of the elimination and the area under the curve could not be calculated.
From the study can be stated that the notified substance is not bioavailable when it is applied once orally under the conditions mentioned above.
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
