Registration Dossier
Registration Dossier
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EC number: 219-514-3 | CAS number: 2451-62-9
Basic toxicokinetics
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 for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- 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:
- 1 983
- 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 substance name:
- 1,3,5-tris(oxiranylmethyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione
- EC Number:
- 219-514-3
- EC Name:
- 1,3,5-tris(oxiranylmethyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione
- Cas Number:
- 2451-62-9
- Molecular formula:
- C12H15N3O6
- IUPAC Name:
- tris[(oxiran-2-yl)methyl]-1,3,5-triazinane-2,4,6-trione
- Details on test material:
- purified alpha-Teroxirone (alpha-TGIC)
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- human
- Sex:
- male/female
- Details on test animals or test system 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)
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