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Toxicological information

Basic toxicokinetics

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Administrative data

Endpoint:
basic toxicokinetics
Type of information:
experimental study
Adequacy of study:
key study
Rationale for reliability incl. deficiencies:
other: no detailed information in SNIF#001-4.5.20-01

Data source

Reference
Reference Type:
other: no information provided
Title:
Unnamed
Year:
1987

Materials and methods

Objective of study:
other: Absorptlon, distribution and excretlon after one application to rat.
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 labelling was achieved by C-14 in both carbons which belong to both pyrrol-rings.
Radiolabelling:
yes

Test animals

Species:
rat

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: suspension in 0.5 % CMC in 0.9 % NaCI
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 radioactivity was found in the urine; 0.3 rsp. 0.4 % were just detected after 24 h in the urine. These small amounts are interpreted as technic-related faecalic impurities.

The part which was incorporated in the faeces were in average 119.7 % (low dose group) rsp. 96.0 %. The corresponding fraction after 24 h was 101.4 % rsp. 79.7 %. In both dosage groups only negligible 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 µg/g (low dosage group) rsp. 1.152 µg/g and in the plasma 0.140 rsp. 1.048 µg/g. The maxima were reached 1 to 2 h after application. As the concentration is closed 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

Conclusions:
Interpretation of results (migrated information): no bioaccumulation potential based on study results
From the study can be stated that the notified substance is not bioavailable when it is applied once orally under the conditions mentioned above.