Dimethyloctadecyl(3-sulphopropyl)ammonium hydroxide

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Link to relevant study records

Reference

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:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

LAUS GmbH Auf der Schafweide 20 D-67489 Kirrweiler

Type of assay:

bacterial reverse mutation assay

Species / strain / cell type:

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

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

S9-mix, rat liver S9-mix induced by Aroclor 1254

Test concentrations with justification for top dose:

Exp 1: 5000, 1500, 500, 150, 50, 15 µg/plate all strains
Exp 1b: 500, 150, 50, 15, 5, 1.5, 0.5 µg/plate TA98(+/-S9), TA100 (+S9), TA1537(+/-S9)
150, 50, 15, 5, 1.5, 0.5, 0.15 µg/plate TA100 (-S9), TA1535 (+/-S9)
Exp. 2: 5000, 2500, 1250, 625, 313, 156, 78 µg/plate TA102 (+/-S9)
500, 250, 125, 63, 31, 16, 7.8 µg/plate TA 98 (+/-S9), TA100 (+S9), TA1537 (+/-S9)
150, 75, 37.5, 18.8, 9.4, 4.7, 2.3 µg/plate TA1535 (+/-S9)
50, 25, 12.5, 6.3, 3.1, 1.6, 0.78 µg/plate TA100 (-S9)

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: ethanol

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

sodium azide

benzo(a)pyrene

other: 4-Nitro-1,2-phenylene diamine, 2-Amino-anthracene

Evaluation criteria:

A result is considered as clearly positive if all following criteria are fulfilled:
> A concentration-related increase, in revertants
> a clear biological relevant increase in at least one concentration compared to the concurrent solvent control
> at least one concentration with an increase above the distribution of historical solvent control data (mean ± 3 SD).

A biologically relevant increase is described as follows:
> if in the bacteria strains TA98, TA100, TA102 the number of revertants is at least twice as high than the reversion rate of the negative controls (increase factor of at least 2.0)
> if in the bacteria strains TA1535 and TA1537 the number of revertants is at least three times higher than the reversion rate of the negative controls (increase factor of at least 3.0).

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

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:

not examined

Positive controls validity:

valid

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Species / strain:

S. typhimurium TA 102

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Conclusions:

The test substance showed no mutagenic effects in the experiment towards 5 S. typhimurium strains.

Executive summary:

The test item showed no mutagenic effects in the experiment. The number of revertant colonies was not increased in comparison with the spontaneous revertants in the treatments with and without metabolic activation using the strains TA98, TA100, TA102, TA 1535 and TA1537.

Cytotoxicity of the test item was detected. The results of the 2nd experiment showed, that none of the tested concentrations induced a relevant or dose-related increase in the number of revertants in all tested strains, in the presence and the absence of metabolic activation.

Therefore, it can be stated, that under the test conditions, the test substance is not mutagenic in the tested strains in the Bacterial Reverse Mutation Test using Salmonella typhimurium, strains TA98, TA100, TA102 TA1535 and TA1537.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)