N,N'-(decane-1,10-diyldi-1(4H)-pyridyl-4-ylidene)bis(octylammonium) dichloride

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:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

N,N'-(decane-1,10-diyldi-1(4H)-pyridyl-4-ylidene)bis(octylammonium) dichloride

EC Number:

274-861-8

EC Name:

N,N'-(decane-1,10-diyldi-1(4H)-pyridyl-4-ylidene)bis(octylammonium) dichloride

Cas Number:

70775-75-6

Molecular formula:

C36H62N4 · 2 HCl

IUPAC Name:

1,1´-Decamethylen-bis[1,4-dihydro-4-(octylimino)pyridine]-dihydrochloride

Test material form:

solid

Specific details on test material used for the study:

Test material Octenidine dihydrochloride
Lot/Batch number Lot No.: 1067998
Specification Octenisept (0.1 % octenidine dihydrochloride)
Description Liquid

Method

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Remarks:

and TA 1538

Metabolic activation:

with and without

Metabolic activation system:

S9 mix, S9 liver microsomal fraction form male Wistar rats induced with Phenobarbital (80 mg/kg bw) and β-Naphtoflavone (100 mg/kg bw)

Test concentrations with justification for top dose:

0.00316, 0.01, 0.0316, 0.1, 2.5 μl/plate, in addition: 5 μl/plate TA 89 and TA 100

Vehicle / solvent:

Test substance was dissolved in Aqua destillata

Controls

Positive controls:

yes

Positive control substance:

sodium azide

methylmethanesulfonate

other: 4-nitro-0-phenylene-diamine, 2-aminoanthracene

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

Octenidine is considered to be non-mutagenic in this bacterial reverse mutation assay.

Executive summary:

Octenidine was tested in the Salmonella/microsome mutagenicty test according tom OECD 471 with the strains TA 98, 100, 102, 1535 and 1537 with and without metabolic activation. It induced no biologically relevant increases in the revertant colony numbers of any of the five test strains at any dose levels with or without metabolic activation. Octenidine is considered to be non-mutagenic in this bacterial reverse mutation assay.