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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:
weight of evidence
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
publication
Title:
Toxicity Studies of Malachite Green Chloride and Leucomalachite Green
Author:
NTP
Year:
2004
Bibliographic source:
National Toxicology Program Toxicity Report Series Number 71

Materials and methods

Principles of method if other than guideline:
Ames test data presented for Malachite Green
GLP compliance:
not specified
Type of assay:
bacterial gene mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strain
Species / strain:
other: s TA97, TA98, TA100, TA102, TA104, and TA1535
Additional strain characteristics:
not specified
Metabolic activation:
with
Metabolic activation system:
metabolic activation enzymes and cofactors from Aroclor 1254-induced male Sprague Dawley rat or Syrian hamster liver
Test concentrations with justification for top dose:
(0.1-10.0 µg/plate)

Results and discussion

Test results
Species / strain:
other: TA97, TA98, TA100, TA102, TA104, or TA1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
not specified
Vehicle controls valid:
not specified
Negative controls valid:
not specified
Positive controls valid:
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

Based on the prediction for in-vitro bacterial reverse mutation assay (e.g. Ames test) on S. typhimurium n TA97, TA98, TA100, TA102, TA104, or TA1535 with or without S9 metabolic activation it was estimated that Malachite green chloride was non mutagenic.
Executive summary:

Based on the prediction for in-vitro bacterial reverse mutation assay (e.g. Ames test) on S. typhimurium n TA97, TA98, TA100, TA102, TA104, or TA1535 with or without S9 metabolic activation it was estimated that Malachite green chloride was non mutagenic.