Registration Dossier
Registration Dossier
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EC number: 207-383-5 | CAS number: 466-99-9
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- 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
Test material
- Reference substance name:
- Monrphinone besylate
- IUPAC Name:
- Monrphinone besylate
1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- 6.67 - 5000 µg/plate (dose finding study)
10 - 5000 µg/plate (initial mutagenicity assay without metabolic activation)
33.3 - 5000 µg/plate (confirmatory assay with metabolic activation)
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO or water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- other: ICR-191, 2-aminoanthracene
- Details on test system and experimental conditions:
- Incubation and sampling times: 52 ± 4 hours at 37°C
Results and discussion
Test results
- Species / strain:
- other: S. typhimurium TA 1535, TA1537, TA98, TA100 and E. coli WP2uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the test the test material was not mutagenic.
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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