1-(3-chlorophenyl)-4-(3-chloropropyl)piperazinium 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)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

2008

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

1-(3-chlorophenyl)-4-(3-chloropropyl)piperazinium chloride

EC Number:

258-038-0

EC Name:

1-(3-chlorophenyl)-4-(3-chloropropyl)piperazinium chloride

Cas Number:

52605-52-4

Molecular formula:

C13H18Cl2N2.ClH

IUPAC Name:

1-(3-chlorophenyl)-4-(3-chloropropyl)piperazin-1-ium chloride

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): AF2335

Method

Target gene:

Histidine

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2

Metabolic activation:

with and without

Metabolic activation system:

S9 mix

Test concentrations with justification for top dose:

Concentrations up to 5000 ug/plate were tested. Other concentrations used were a series of ca half-log 10 dilutions of the highest concentration.

Vehicle / solvent:

DMSO

Controls

Untreated negative controls:

yes

Remarks:

DMSO

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2

Genotoxicity:

positive

Remarks:

with metabolic activation

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at 5000 ug/plate in both tests

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Toxicity (observed as a sparse background lawn of non-revertant colonies, togheter with a reduction in revertant colony numbers) was seen in all strains following exposure at 5000 ug/plate in the presence of S9 mix in both tests.

Toxicity (observed as a reduction in revertant colony numbers) was also seen in strain WP2 uvrA (pKM101) following exposure at 5000 ug/plate in the absence of S9 mix in both tests.

Substancial, concentration-related increases in reversion to prototrophy were obtained in strain TA1535 following exposure to AF2335 in the presence of S9 mix. Increases reached 6.4 x and 5.1 x vehicle control counts in tests 1 and 2 respectively, with AF2335 at 1500 ug/plate.

No clear evidence of mutagenic activity was seen at any concentration in any other strain in either mutation test.

The concurrent positive controls demonstrated the sensitivity of the assay and the metabolising activity of the liver preparations. The mean revertant colony counts for the vehicle controls were within or close to the 99% confidence limits of the current historical control range of the laboratory.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
positive

It is concluded that AF2335 exhibited mutagenic activity in this bacterial system following metabolic activation.