Registration Dossier
Registration Dossier
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EC number: 207-383-5 | CAS number: 466-99-9
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- 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:
- yes
- Type of assay:
- mammalian erythrocyte micronucleus test
Test material
- Reference substance name:
- Monrphinone besylate
- IUPAC Name:
- Monrphinone besylate
1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male
Administration / exposure
- Route of administration:
- oral: gavage
- Duration of treatment / exposure:
- 50, 100, 200 mg/kg administered BID separated by 1 hour for total dose of 100, 200 and 400 mg/kg as a single oral gavage dose at 15 mL/kg
- No. of animals per sex per dose:
- 6 males per dose
- Control animals:
- yes
- Positive control(s):
- cyclophosphamide (80 mg/kg)
Examinations
- Details of tissue and slide preparation:
- Incubation and sampling times: 24 and 48 hours after administration
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- yes
- Negative controls validity:
- not specified
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- The test material was not clastogenic under the condtions of the test.
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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