Registration Dossier

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:
other: 88/302/EEC PART B
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Details of label:
The labeling was achieved by C-14 in both carbons which belong to both pyrrol-rings.
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:
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