(4-(4-aminophenyl)(4-iminocyclohexa-2,5-dienylidene)methyl)-2-methylaniline hydrochloride

Genetic toxicity: in vitro

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

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

Test material information

Constituent 1

Reference substance name:

(4-(4-aminophenyl)(4-iminocyclohexa-2,5-dienylidene)methyl)-2-methylaniline hydrochloride

EC Number:

211-189-6

EC Name:

(4-(4-aminophenyl)(4-iminocyclohexa-2,5-dienylidene)methyl)-2-methylaniline hydrochloride

Cas Number:

632-99-5

Molecular formula:

C20H19N3.ClH

IUPAC Name:

(4-(4-aminophenyl)(4-iminocyclohexa-2,5-dienylidene)methyl)-2-methylaniline hydrochloride

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.