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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

Constituent 1
Reference substance name:
[4-[α-[4-(dimethylamino)phenyl]benzylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride
EC Number:
209-322-8
EC Name:
[4-[α-[4-(dimethylamino)phenyl]benzylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride
Cas Number:
569-64-2
IUPAC Name:
N-(4-{[4-(dimethylamino)phenyl](phenyl)methylene}cyclohexa-2,5-dien-1-ylidene)-N-methylmethanaminium chloride

Method

Species / strain
Species / strain / cell type:
other: s TA97, TA98, TA100, TA102, TA104, and TA1535
Additional strain / cell type 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:
S. typhimurium, other: TA97, TA98, TA100, TA102, TA104, or TA1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
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.