Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics
Type of information:
other: expert statement
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Objective of study:
toxicokinetics
Test guideline
Qualifier:
no guideline required
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): no bioaccumulation potential based on study results see also bioaccumulation study
Specific information on the metabolism and excretion of the substance is not available. Metabolism of CCP-V-1 in the liver can be assumed, because the liver was found to be a target organ in the repeat dose toxicity study as a result of metabolic adaptation (28d: key study). Because of the reversibility of the observed effects (e.g. on liver), the substance is most likely eliminated from the body. Due to the molecular properties of CCP-V-1, excretion via the kidneys is considered to be the main route of elimination.
Executive summary:

Resorption

Because of the molecular structure, low molecular weight (282.47 g/mol) and octanol-water partition coefficient (>4.7), resorption of CCP-V-1 via the gastrointestinal tract is considered to be likely. After single treatment of rats with CCP-V-1 at a dose of 2000 mg/kg bw no signs of toxicity were observed (acute oral: key study). In the repeat dose toxicity study with rats, systemic effects were reported after oral administration of 1000 and 200 mg/kg bw. These effects included mortality in the high dose group of 1000 mg/kg. At 200 and 1000 mg/kg bw, the animals showed changes in haematological and clinical chemical parameters indicating a dose-dependent effect on liver, adrenals and testes after 4 weeks of treatment with CCP-V-1 (28d: key study). From these effects it can be concluded that the compound is resorbed after oral administration.

Distribution

Due to the low water solubility and the high octanol/water-coefficient, in combination with the low molecular weight permeation of membranes is assumed to be possible. The toxicological effects found in the repeat dose toxicity study (28d: key study) clearly show that the compound is distributed throughout the body after oral uptake and is thus systemically available.

Metabolism and Excretion

Specific information on the metabolism and excretion of the substance is not available. Metabolism of CCP-V-1 in the liver can be assumed, because the liver was found to be a target organ in the repeat dose toxicity study as a result of metabolic adaptation (28d: key study). Because of the reversibility of the observed effects (e.g. on liver), the substance is most likely eliminated from the body. Due to the molecular properties of CCP-V-1, excretion via the kidneys is considered to be the main route of elimination.