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Toxicological information

Basic toxicokinetics

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Administrative data

Endpoint:
basic toxicokinetics in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2013 / 2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report Date:
2014

Materials and methods

Objective of study:
toxicokinetics
Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 417 (Toxicokinetics)
Qualifier:
according to
Guideline:
other: Chemical Testing Methods - Health Effects Volume, Beijing: Cina Environmental Science press. 2013.09.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: bulk
Details on test material:
Batch ST02697671
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: ST02697671
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature, sealed
Radiolabelling:
no

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Experimental Animal Center of Zhejiang Province
- Age at study initiation: 6 - 8 weeks old
- Weight at study initiation: -
- Housing: stainless steel wire cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 26 °C
- Humidity (%): 40 - 70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light):12/12

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
physiological saline
Doses / concentrations
Dose / conc.:
450 mg/kg bw (total dose)
No. of animals per sex per dose:
3
Control animals:
not specified
Details on dosing and sampling:
TOXICOKINETIC / PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled (delete / add / specify): plasma
- Time and frequency of sampling: before exposure and after 5 min, 20 min, 40 min, 1 h, 2 h, 6 h, and 24 h.

Results and discussion

Preliminary studies:
The structure of REWOSOFT TE 19L was analyzed and found that there were three compounds which have a higher relative amount.
Main ADME results
Type:
distribution
Results:
the 3 compounds of Rewosoft TE 19L were not detected in plasma at the different time points.

Metabolite characterisation studies

Metabolites identified:
not specified

Bioaccessibility

Bioaccessibility testing results:
The stability of these three compounds in rat whole blood, rat plasma, and rat blood cells was studied. It was found that these three compounds are very unstable incubated in rat whole blood at 37°C, suggesting that they are also not stable in vivo.

Applicant's summary and conclusion

Conclusions:
The stability of three compounds of Rewosoft TE 19L in rat whole blood, rat plasma and rat blood cells was studied. It was found, that the instability in vivo was too high to determine its distribution.