Reaction mass of benzyldodecylbis(2-hydroxypropyl)ammonium chloride and benzylbis(2-hydroxypropyl)tetradecylammonium 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: well documented guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Principles of method if other than guideline:

The mutagenic potential of m-tolylisocyanate was examined in the Salmonella/microsome test. Bacteria of 5 histidineauxotrophic Salmonella typhimurium LT2 mutant strains (TA 98, TA 100, TA 102, TA 1535, and TA 1537) were exposed to doses up to 5000 pg per plate. Both the plate incorporation method and the preincubation method was used.

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Benzyldodecylbis(2-hydroxypropyl)ammonium chloride

EC Number:

265-345-3

EC Name:

Benzyldodecylbis(2-hydroxypropyl)ammonium chloride

Cas Number:

65059-91-8

Molecular formula:

C25H46NO2.Cl

IUPAC Name:

N-benzyl-N,N-bis(2-hydroxypropyl)dodecan-1-aminium chloride

Details on test material:

Catalysator WAZ 5596-B, content: 55-60 %

Method

Species / strain

Species / strain / cell type:

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

Additional strain / cell type characteristics:

other: Firstly, they are deep rough since certain lipopolysaccharide side chains are missing in the bacterial cell wall. Secondly, their reduced ability to repair damage from UV light (e.g. thymidine dimers) allows the phenotypic detection of mutation events

Metabolic activation:

with and without

Metabolic activation system:

S 9-mix

Test concentrations with justification for top dose:

Plate incorporation method: up to and including 160 µg/plate;
Preincubation method: up to and including 128 µg/plate

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: sodium azide, nitrofurantoin, 4-nitro-1,2-phenylene diamine, mitomycin C, cumene hydroperoxide and 2-aminoanthracene

Results and discussion

Test results

Species / strain:

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

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

plate incorporation test: 10 µg/plate; preincubation test: 2 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

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

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

In the plate incorporation test doses of up to and including 10 µg per plate did not cause any bacteriotoxic effects. At higher doses, the substance had a strong, strainspecific bacteriotoxic effect, so that this range could only be used up to and including 80 µg per plate for assessment purposes.

In the preincubation test doses of up to and including 2 µg per plate did not cause any bacteriotoxic effects. At higher doses, the substance had a strong, strain-specific bacteriotoxic effect, so that this range could only be used up to and including 64 µg per plate for assessment purposes.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

Executive summary:

Katalysator WAZ 5596-8 was initially investigated using the Salmonella/microsome plate incorporation test for point mutagenic effects in doses of up to and including 5000 µg per plate on five Salmonella typhimurium L T2 mutants. An independent repeat

was performed as preincubation for 20 minutes at 37°C with doses of up to and including 160 µg per plate. These comprised the histidine-auxotrophic strains TA 1535, TA 100, TA 1537, TA 98 and TA 102. Other conditions remained unchanged. Due to the strong bacteriotoxic effects a second plate incorporation test with doses of up to and including 160 µg per plate and a further preincubation test was performed employing doses of up to and including 128 µg per plate.

In the plate incorporation test doses of up to and including 10 µg per plate did not cause any bacteriotoxic effects. At higher doses, the substance had a strong, strainspecific bacteriotoxic effect, so that this range could only be used up to and including 80 µg per plate for assessment purposes.

In the preincubation test doses of up to and including 2 µg per plate did not cause any bacteriotoxic effects. At higher doses, the substance had a strong, strain-specific bacteriotoxic effect, so that this range could only be used up to and including 64 µg per plate for assessment purposes.

Evidence of mutagenic activity of Katalysator WAl 5596-8 was not seen. No biologically relevant increase in the mutant count, in comparison to the negative controls, was observed in any of the strains tested, without and with S9 mix, in the plate incorporation

as weil as in the preincubation modification, under the experimental conditions applied.

The positive controls sodium azide, nitrofurantoin, 4-nitro-1,2-phenylene diamine, mitomycin C, cu me ne hydroperoxide and 2-aminoanthracene had a marked mutagenic effect, as was seen by a biologically relevant increase in mutant colonies compared

to the corresponding negative controls.

Therefore, Katalysator WAZ 5596-8 is considered to be non-mutagenic in the Salmonella/microsome test.