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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:
key study
Study period:
not stated
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Similar to OECD guidelines. However, only four bacterial strains were tested (TA 1535 omitted).

Data source

Reference
Reference Type:
publication
Title:
Cyto- and genotoxic effects of coordination complexes of platinum, palladium and rhodium in vitro
Author:
Bunger J. et al.
Year:
1996
Bibliographic source:
International Archives of Environmental Health, 69, 33-38

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: Revised test protocol of Maron and Ames (1983)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
The study differred principally from OECD TG471 in that only four bacterial strains were tested. The recommended strain TA1535 was ommitted.
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Method

Target gene:
Histidine operon
Species / strain
Species / strain / cell type:
other: TA97a, TA98, TA100 and TA102
Metabolic activation:
with and without
Metabolic activation system:
Sprague-Dawley rat liver, Induced with phenobarbital and beta-naphthoflavone
Test concentrations with justification for top dose:
The test substance was dissolved in distilled water and diluted to 5-500 ug/plate [or possibly 10, 50, 100 or 500 ug/plate] in all four tester strains, in the absence or presence of (4% and 10%) S9. The number of revertant colonies on the plates were recorded after 48 hours of incubation in the dark at 37degC.
Controlsopen allclose all
Negative solvent / vehicle controls:
yes
Remarks:
Distilled water
Positive controls:
yes
Positive control substance:
methylmethanesulfonate
Positive controls:
yes
Positive control substance:
other: 2-aminofluorene
Details on test system and experimental conditions:
Tests were done in duplicate at least three times.
Evaluation criteria:
For the test substance to be considered mutagenic, a two-fold (or more) increase in the mean revertant numbers must be observed in the plates containing the test substanced compared to the spontaneous reversion rate.

Results and discussion

Test resultsopen allclose all
Species / strain:
other: TA97a, TA98, TA100 and TA102
Metabolic activation:
with
Genotoxicity:
positive
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Species / strain:
other: TA98, TA100 and TA102
Metabolic activation:
without
Genotoxicity:
positive
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Species / strain:
other: TA97a
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Additional information on results:
The test substance caused a 2- to greater than 10-fold increase in revertants in all four tester strains (compared with spontaneous reversion rates), in the presence of S9. In the absence of S9, a 2- to 10-fold increase in reversion rates was seen in three tester strains, whereas in TA97a no mutagenic effect was evident. "The increase in reverse mutation rates in the samples that tested positive was dosage-dependent",

Any other information on results incl. tables

High doses of the metal compounds proved toxic to the tester strains", resulting in a thinning of the background bacterial lawn. Although no actual data provided for potassium hexachloroplatinate, the minimum toxic dose for the platinum salts was apparently 100 ug/plate.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
positive

Dipotassium hexachloroplatinate was mutagenic in a bacterial reverse mutation (Ames) assay using four Salmonella typhimurium strains (TA97a, TA98, TA100 and TA102) when tested in the presence and absence of a rat liver metabolic activation (S9) system.
Executive summary:

Dipotassium hexachloroplatinate was assessed for mutagenic activity in a bacterial reverse mutation (Ames) assay, similar to OECD Test Guideline 471, using Salmonella typhimurium strains TA97a, TA98, TA100 and TA102 and tested at up to 500 μg/plate in both the presence and absence of a metabolic activation system (S9) derived from phenobarbital and beta-naphthoflavone induced rat livers.

 

Mutagenic effects were seen in all four strains in the presence of metabolic activation and in all but strain TA97a in its absence. Although no cytotoxicity data were provided for the test material, the minimum toxic dose for the platinum salts was apparently 100 μg/plate.