Registration Dossier

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2002

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
Version / remarks:
umu test
GLP compliance:
not specified
Type of assay:
SOS/umu assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Specific details on test material used for the study:
purity > 99.9%

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535
Metabolic activation:
with and without
Metabolic activation system:
S-9 mix: a mixture of the microsome fraction of a rat liver with coenzymes such as reduced nicotinamide adenine dinucleotide phosphate and reduced nicotinamide adenine dinucleotide, was used
Test concentrations with justification for top dose:
at least 6 concentrations, ranging from 7.2 × 10−7 to 1.4 × 10−4 mol/L
Vehicle / solvent:
In advance of mutagenic evaluation, each of the salts was dissolved in and diluted with sterile Dulbecco’s phosphate- buffered saline without calcium and magnesium salts [PBS(−)] to prepare a proper metal salt solution, which would provide a desired final concentration of the salt in the medium.
Controls
Untreated negative controls:
yes
Remarks:
PBS
Positive controls:
yes
Positive control substance:
furylfuramide
other: 2-aminoanthracene

Results and discussion

Test results
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity

Applicant's summary and conclusion

Conclusions:
The test item Gallium trichloride is not mutagenic, with or without metabolic activation (S9 mix).
Executive summary:

The test item Gallium trichloride is not mutagenic, with or without metabolic activation (S9 mix).