Registration Dossier
Registration Dossier
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EC number: 609-335-2 | CAS number: 3717-40-6
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Only secondary literature.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- American Hospital Formulary Service - Drug Information 2005
- Author:
- McEvoy, GK
- Year:
- 2 005
- Bibliographic source:
- American Society of Health-System Pharmacists, Inc. 2005 (Plus Supplements)., p. 592
- Reference Type:
- publication
- Title:
- Update on genotoxicity and carcinogenicity testing of 472 marketed pharmaceuticals.
- Author:
- Brambilla G, Martelli A
- Year:
- 2 009
- Bibliographic source:
- Mutat Res. 681(2-3), 209-29
Materials and methods
- Principles of method if other than guideline:
- Ames microbial test with or without metabolic activation using Salmonella typhimurium.
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Amantadine
- EC Number:
- 212-201-2
- EC Name:
- Amantadine
- Cas Number:
- 768-94-5
- IUPAC Name:
- adamantan-1-amine
- Details on test material:
- - Name of test material (as cited in study report): Amantadine
- No further details
Constituent 1
Method
- Target gene:
- his operon
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: no strains specified
- Details on mammalian cell type (if applicable):
- not applicable
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- no data
- Test concentrations with justification for top dose:
- no data
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- not specified
- Positive control substance:
- not specified
Results and discussion
Test results
- Species / strain:
- not specified
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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