Registration Dossier
Registration Dossier
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EC number: 207-383-5 | CAS number: 466-99-9
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
- Remarks:
- Conducted on a read-across material.
- Justification for type of information:
- The toxicological profile of the test material would not be different than that of the read-across material. Data is used to support the registered substance’s products in regulatory submissions.
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- PHARMACOLOGY/TOXICOLOGY NDA REVIEW AND EVALUATION
- Author:
- Thornton-Jones SR
- Year:
- 2 004
- Bibliographic source:
- NDA 21-044, DEPARTMENT OF HEALTH AND HUMAN SERVICES, PUBLIC HEALTH SERVICE, FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH
Materials and methods
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Monrphinone besylate
- IUPAC Name:
- Monrphinone besylate
1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 8 - 10 weeks
- Weight at study initiation: 22 - 30 g
Administration / exposure
- Route of administration:
- oral: gavage
- Doses:
- 100, 200, 300 mg/kg
- No. of animals per sex per dose:
- 4
- Control animals:
- not specified
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 300 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: At 300 mg/kg 1 of 4 female mice died.
- Mortality:
- One female died at 300 mg/kg
- Clinical signs:
- Hypoactivity, tremors, erect posture
- Body weight:
- Decrease in one 300 mg/kg female
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Under the conditions of the study, the acute oral LD50 was > 300 mg/kg.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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