Registration Dossier
Registration Dossier
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EC number: 200-592-2 | CAS number: 64-73-3
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: provide necessary information without detailed specification
Data source
Reference
- Reference Type:
- publication
- Title:
- a compilation of LD 50 values in newborn and adult animals
- Author:
- EDWIN I. GOLDENTHAL
- Year:
- 1 971
- Bibliographic source:
- toxicology and applied pharmacology 18, 185-207(1971)
- Report date:
- 1970
Materials and methods
Test material
- Reference substance name:
- Demethychlortetracycline HCL
- IUPAC Name:
- Demethychlortetracycline HCL
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- not specified
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
Results and discussion
Effect levelsopen allclose all
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 2 107 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 1 760 - < 2 435
- Remarks on result:
- other: for adult
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 2 372 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 1 908 - < 2 905
- Remarks on result:
- other: for newborn (< 2 days)
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- LD 50(oral, adult rats): 2372 mg/kg/day;
LD 50(oral, newborn rats (< 2 days)): 2107 mg/kg/day - Executive summary:
In this literature, it presented consists primarily of data submitted in drug applications from pharmaceutial manufactures without a detailed specification. However, necessary experimetal data was provided in this study to evaluate the acute oral toxicity on test article. It has been indicated that LD50(oral, adult rats) is 2372 mg/kg and LD50 (oral, newborn rats(< 2 days)) is 2107 mg/kg.
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