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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

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

Constituent 1
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

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