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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data

Data source

Reference
Reference Type:
publication
Title:
STUDIES ON THE PHARMACOKINETICS AND MUTAGENIC POTENTIAL OF RHODAMINE B
Author:
ELLIOTT,GS, MASON,RW AND EDWARDS,IR
Year:
1990
Bibliographic source:
TOXNET CCRIS citing this publication (J. TOXICOL., CLIN. TOXICOL. 28(1):45-59, 1990)

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 98
Metabolic activation:
with and without
Metabolic activation system:
RAT, LIVER, S-9, BETA-NAPHTHOFLAVONE AND PHENOBARBITAL
Test concentrations with justification for top dose:
0.01-4 MG/PLATE OF COMMERCIAL RHODAMINE B500
Vehicle / solvent:
distilled water
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
not specified
Details on test system and experimental conditions:
preincubation test

Results and discussion

Test results
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with
Genotoxicity:
positive
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified

Applicant's summary and conclusion

Conclusions:
In an Ames test using the pre-incubation method, basic violet 10 was found positive in S. typhimurium strain TA98 with metabolic activation, when tested at doses of 0.01 to 4 mg/plate in distilled water.
The results do not support the hypothesis that rhodamine B is a genotoxic hazard in the mammalian organism