Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics
Type of information:
calculation (if not (Q)SAR)
Remarks:
Migrated phrase: estimated by calculation
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2005

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Radiolabelling:
no

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on absorption:
The substance and / or its degradation products are absorbed by oral route since systemic effects are noted after exposure by this route.
(Based on the base-set data)
Details on distribution in tissues:
Based on in-vitro data indicating that a slight difference in toxicity was noted in assays with and without metabolic activation system, the substance
MENAPHTACYAN could be metabolized by hepatic microsomal fractions. Centrilobular hepatocellular hypertrophy shows that the substance and/or its degradation products are probably metabolized by this organ. (corroboreted by in-vitro data)
Details on excretion:
In the absence of effects on kidneys, it is difficult to indicate if MENAPHTACYAN is excreted by this organ.
On the basis of the log P, MENAPHTACYAN could have a weak potential to bioaccumulate

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): low bioaccumulation potential based on study results