Registration Dossier
Registration Dossier
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EC number: 215-818-5 | CAS number: 1420-53-7
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- PHARMACOLOGY/TOXICOLOGY NDA REVIEW AND EVALUATION
- Author:
- Delatte MS
- Year:
- 2 010
- Bibliographic source:
- NDA 202245, DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Not specified
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Codeine
- EC Number:
- 200-969-1
- EC Name:
- Codeine
- Cas Number:
- 76-57-3
- Molecular formula:
- C18H21NO3
- IUPAC Name:
- Codeine
1
Test animals
- Species:
- other: Rats and mice
Results and discussion
Effect levelsopen allclose all
- Sex:
- not specified
- Dose descriptor:
- LD50
- Remarks:
- Mice
- Effect level:
- 250 mg/kg bw
- Based on:
- not specified
- Sex:
- not specified
- Dose descriptor:
- LD50
- Remarks:
- Rats
- Effect level:
- 427 mg/kg bw
- Based on:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Mouse: LD50 is 250 mg/kg.
Rat: LD50 is 427 mg/kg.
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