1-benzyl-3-carboxylatopyridinium sodium chloride

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP Guideline Study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

1-benzyl-3-carboxylatopyridinium sodium chloride

EC Number:

268-692-9

EC Name:

1-benzyl-3-carboxylatopyridinium sodium chloride

Cas Number:

68133-60-8

Molecular formula:

C13H12NO2.Cl.Na

IUPAC Name:

1-benzyl-3-carboxylatopyridinium sodium chloride

Details on test material:

- Name of test material (as cited in study report): LUGALVAN BPC dry
- Physical state: solid
- Analytical purity: 95.5 area-%
- Lot/batch No.: 467602
- Stability under test conditions: The stability under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility.

Method

Target gene:

HIS/TRP

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Additional strain / cell type characteristics:

not applicable

Species / strain 2

Species / strain / cell type:

E. coli WP2 uvr A

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

S9-mix

Test concentrations with justification for top dose:

33 μg - 5 200 μg/plate (SPT)
33 μg - 5 200 μg/plate (SPT)

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: [water]
- Justification for choice of solvent/vehicle: Due to the good solubility of the test substance in ultrapure water, ultrapure water was used as vehicle.

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

4-nitroquinoline-N-oxide

9-aminoacridine

other: 2-aminoanthracene (2-AA), N-methyl-N'-nitro-N-nitrosoguanidine (MNNG), 4-nitro-o-phenylenediamine (NOPD)

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation); preincubation

DURATION
- Incubation period: 20 min in medium (PIT) and incubation at 37°C for 48 – 72 hours (PIT and SPT)

DETERMINATION OF CYTOTOXICITY
- Method: relative total growth

Evaluation criteria:

The test substance is considered positive in this assay if the following criteria are met:
• A dose-related and reproducible increase in the number of revertant colonies, i.e. about doubling of the spontaneous mutation rate in at least one tester strain either without S9 mix or after adding a metabolizing system.
A test substance is generally considered non-mutagenic in this test if:
• The number of revertants for all tester strains were within the historical negative control range under all experimental conditions in at least two experiments carried out independently of each other.

Statistics:

not applicable

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

ADDITIONAL INFORMATION ON CYTOTOXICITY:
No bacteriotoxic effect (reduced his- or trp- background growth, slight decrease in the number of his+ or trp+ revertants, slight reduction in the titer) was observed in the standard plate test and in the preincubation test up to the highest required concentration.
The inconclusive Data observed in the 1st standard plate test was not confirmed in the repeat experiment and has to be considered as not relevant.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

According to the results of the present study, the test substance did not lead to a biologically

relevant increase in the number of revertant colonies either without S9 mix or after adding a

metabolizing system in three experiments carried out independently of each other (standard

plate test and preincubation assay).

Besides, the results of the negative as well as the positive controls performed in parallel

corroborated the validity of this study, since the values fulfilled the acceptance criteria of this

study.

In this study with and without S9 mix, the number of revertant colonies in the negative

controls was within or nearby the range of the historical negative control data for each tester

strain.

In addition, the positive control substances both with and without S9 mix induced a significant

increase in the number of revertant colonies within the range of the historical positive control

data or above.