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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:
supporting study
Study period:
1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: no GLP, no guidelines, but peer-reviewed journal
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
publication
Title:
Phase-I Study if alpha-1,3,5-Triglycidyl-s-triazinetrione (NSC 296934).
Author:
Dombernowsky, P., Lund, B., Hansen, H.H.
Year:
1983
Bibliographic source:
Cancer chemother. Pharmacol. 11, 59-61 (1983).
Report Date:
1983

Materials and methods

Objective of study:
toxicokinetics
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Phase-1 clinical trial
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
purified alpha-Teroxirone (alpha-TGIC)
Radiolabelling:
no

Test animals

Species:
human
Sex:
male/female
Details on test animals and environmental conditions:
termonal cancer patients aged 29-69 years, 39 patients

Administration / exposure

Route of administration:
intravenous
Vehicle:
physiological saline
Details on exposure:
single doses, repeated every 3-4 weeks with increasing dose
Doses / concentrations
Remarks:
Doses / Concentrations:
30 - 2700 mg/m2 of body surface

Results and discussion

Preliminary studies:
none

Any other information on results incl. tables

Doses as high as 1800 mg/m2 showed moderate to severe sings of toxicity such as leukopenia, phlebitis, nausea and vomitting and alopecia. In some patients platelet counts were 10 times lower after dosing with 2700 mg/m2.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): no bioaccumulation potential based on study results
From this study it is recommended to perform further trials with more tolerable formulations of TGIC (other than physiological salt solution)
Executive summary:

From this study it is recommended to perform further trials with more tolerable formulations of TGIC (other than physiological salt solution)