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Diss Factsheets

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Remarks:
Salbutamol sulfate
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data from "Peer reviewed".

Data source

Reference
Reference Type:
review article or handbook
Title:
Thomson.Micromedex. Drug Information for the Health Care Professional. 24th ed. Volume 1. Plus Updates
Year:
2004
Bibliographic source:
Toxnet database (https://toxnet.nlm.nih.gov)

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Salbutamol
EC Number:
242-424-0
EC Name:
Salbutamol
Cas Number:
18559-94-9
Molecular formula:
C13H21NO3
IUPAC Name:
4-[2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol
Test material form:
solid: particulate/powder

Method

Target gene:
S. typhimurium TA1537, TA1538, and TA98 or E. Coli WP2, WP2uvrA, and WP67.
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1538
Species / strain / cell type:
S. typhimurium TA 1537
Species / strain / cell type:
S. typhimurium TA 98
Species / strain / cell type:
E. coli WP2
Species / strain / cell type:
E. coli WP2 uvr A
Species / strain / cell type:
E. coli, other: WP67
Metabolic activation:
with and without

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Species / strain:
E. coli, other: WP2, WP2uvrA, and WP67
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified

Any other information on results incl. tables

No forward mutation occurred in yeast strain Saccharomyces cerevisiae S9 nor any mitotic gene conversion in yeast

S. cerevisiae JD1 with or without metabolic activation. Results of fluctuation assays in S. typhimurium TA98 and E.

coli WP2, both with metabolic activation, were negative.

Applicant's summary and conclusion

Conclusions:
Not mutagenic in the Ames test with or without metabolic activation using tester strains S. typhimurium TA1537, TA1538, and TA98 or E. Coli WP2, WP2uvrA, and WP67.