Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

According to the umu test with or without metabolic activation (S9 mix), the test item Gallium trichloride is not mutagenic.

Link to relevant study records
Reference
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
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
Specific details on test material used for the study:
purity > 99.9%
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.
Untreated negative controls:
yes
Remarks:
PBS
Positive controls:
yes
Positive control substance:
furylfuramide
other: 2-aminoanthracene
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
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).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

According to the umu test with or without metabolic activation (S9 mix), the test item Gallium trichloride is not mutagenic.