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Toxicological information

Genetic toxicity: in vitro

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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:
2005
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:
2009
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
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Amantadine
- No further details

Method

Target gene:
his operon
Species / strain
Species / strain:
other: no strains specified
Details on mammalian cell lines (if applicable):
not applicable
Additional strain characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
no data
Test concentrations with justification for top dose:
no data
Controls
Negative controls:
not specified
Solvent 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:
not specified
Vehicle controls valid:
not specified
Negative controls valid:
not specified
Positive controls valid:
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