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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
Justification for type of information:
Data is from CCRIS

Data source

Reference
Reference Type:
review article or handbook
Title:
In vitro genetic mutation study for Basic Fuchsin
Author:
U. S. National Library of Medicine
Year:
2017
Bibliographic source:
CCRIS ; US national Library of Medicine reviewed by SRC, 2017

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: As mention below
Principles of method if other than guideline:
To evaluate the mutagenic potential of Magenta in Salmonella typhimurium TA98, TA 100, TA 1535, 1537,TA 1538 and E.Coli WP2UVRA.
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
IUPAC name:((4-(4-aminophenyl)(4-iminocyclohexa-2,5-dienylidene)methyl)-2-methylaniline hydrochloride)
commen name : Basic violet 14
Molecular formula :C20H19N3.ClH
molecular weight: 337.8 g/mol
InChI:1S/C20H19N3.ClH/c1-13-12-16(6-11-19(13)23)20(14-2-7-17(21)8-3-14)15-4-9-18(22)10-5-15;/h2-12,21H,22-23H2,1H3;1H/b20-14-,21-17?
Smiles:C(\c1cc(c(N)cc1)C)(c1ccc(N)cc1)=C1/C=CC(=N)C=C1.Cl
Specific details on test material used for the study:
IUPAC name:Magenta
commen name : Basic violet 14
Molecular formula :C20H19N3.ClH
molecular weight: 337.8 g/mol
InChI:1S/C20H19N3.ClH/c1-13-12-16(6-11-19(13)23)20(14-2-7-17(21)8-3-14)15-4-9-18(22)10-5-15;/h2-12,21H,22-23H2,1H3;1H/b20-14-,21-17?
Smiles:C(\c1cc(c(N)cc1)C)(c1ccc(N)cc1)=C1/C=CC(=N)C=C1.Cl

Method

Target gene:
Histidine for Salmonella typhimurium and tryptophan for E.Coli.
Species / strain
Species / strain / cell type:
bacteria, other: Salmonella typhimurium TA98, TA 100, TA 1535, 1537, TA 1538and E.Coli WP2UVRA.
Details on mammalian cell type (if applicable):
Not apllicable
Additional strain / cell type characteristics:
not specified
Cytokinesis block (if used):
not specified
Metabolic activation:
with and without
Metabolic activation system:
Rat liver S-9, Phenobarbital and Beta-naphthoflavone
Test concentrations with justification for top dose:
-S9; 5-1000 µg/plate for TA98, TA 100and E.Coli WP2UVRA.
-S9; 1-200 µg/plate for TA 1535, 1537 and TA 1538
+S9;20-5000µg/plate ,For all strain
Vehicle / solvent:
Vehicle
- Vehicle(s)/solvent(s) used: DMSO
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
True negative controls:
not specified
Positive controls:
not specified
Details on test system and experimental conditions:
Details on test system and conditions
METHOD OF APPLICATION: Preincubation
Rationale for test conditions:
Not specified
Evaluation criteria:
Evaluation was done considering a dose dependent increase in the number of revertants/plate.
Statistics:
Not specified

Results and discussion

Test results
Key result
Species / strain:
bacteria, other: Salmonella typhimurium TA98, TA 100, TA 1535, 1537,TA 1538 and E.Coli WP2UVRA.
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Remarks on result:
other: No mutagenic effect were observed

Applicant's summary and conclusion

Conclusions:
Magenta (632-99-5) was evaluated for its mutagenic potential in Salmonella typhimurium TA98, TA 100, TA 1535, 1537, TA 1538 and E.Coli WP2UVRA. The test results were considered to be negative in the presence and absence of S9.
Executive summary:

In the study Magenta was assessed for its possible mutagenic potential. For this purpose the reverse mutation assay was performed on Salmonella typhimurium TA98, TA 100, TA 1535, 1537, TA 1538 and E.Coli WP2UVRA.t material was exposed at the concentration of 5-1000 µg/plate for TA98, TA 100, E.Coli WP2UVRA and 1-200 µg/plate for TA 1535, 1537,TA 1538 in the absence of S9 metabolic activation. While all strains were exposed to the test material at the concentration of 20-5000µg/plate in the presence of S9.Cytotoxicity was also observed. No mutagenic effects were observed. Therefore Magenta was considered to be non mutagenic with and without S9. Hence the substance cannot be classified as gene mutant in vitro.