Dimethylaminopropylmethacrylamide, dodecyl bromide

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17/08/2021

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

2022

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

30/05/2008

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

2020

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-(3-methacrylamidopropyl)-N,N-dimethyldodecan-1-aminium bromide

Cas Number:

129684-50-0

Molecular formula:

C21H43N2O.Br

IUPAC Name:

N-(3-methacrylamidopropyl)-N,N-dimethyldodecan-1-aminium bromide

Test material form:

liquid: viscous

Method

Species / strain

Species / strain 1

Species / strain / cell type:

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

Species / strain 2

Species / strain / cell type:

E. coli WP2 uvr A

Metabolic activation:

with and without

Metabolic activation system:

Microsomal preparation derived from Phenobarbital/5,6-Benzoflavon-induced rat liver

Test concentrations with justification for top dose:

Preliminary test
Dimethylaminopropylmethacrylamide, dodecyl bromide was examined in two preliminary cytotoxicity tests (plate incorporation test without and with metabolic activation) in the test strain TA100. Ten concentrations ranging from 0.316 µg/plate up to the top concentration 5000 µg Dimethylaminopropylmethacrylamide, dodecyl bromide/plate were tested. Cytotoxicity was observed starting at a concentration of 100 µg/plate in the plate incorporation test without metabolic activation and at a concentration of 31.6 µg/plate with metabolic activation. No test item precipitation was noted.
Hence, 100 µg Dimethylaminopropylmethacrylamide, dodecyl bromide/plate were also chosen as top concentration in both experiments of the main study.

Main study
Six concentrations ranging from 0.316 to 100 µg Dimethylaminopropylmethacrylamide, dodecyl bromide/plate were employed in the plate incorporation test and the preincubation test without or with metabolic activation, respectively.

Vehicle / solvent:

Dimethyl sulfoxide (DMSO).

Controls

Negative solvent / vehicle controls:

yes

Remarks:

Dimethyl sulfoxide (DMSO).

Positive controls:

yes

Details on test system and experimental conditions:

The preliminary cytotoxicity test was performed with the Salmonella typhimurium strain TA100 starting at a concentration of 0.316 µg per plate up to the recommended maximum soluble test concentration of 5000 µg Dimethylaminopropylmethacrylamide, dodecyl bromide per plate in the plate incorporation test. Cytotoxicity was observed starting at a concentration of 100 µg/plate without metabolic activation and at a concentration of 31.6 µg/plate with metabolic activation. No test item precipitation was noted.
Based on this preliminary experiment the main study tests were performed with the Salmonella typhimurium strains TA98, TA100, TA1535, TA1537 and the Escherichia coli strain WP2 uvrA. Six different concentrations of the test item were tested in with half-log intervals between plates (0.316, 1.00, 3.16, 10.0, 31.6 and 100 µg Dimethylaminopropylmethacrylamide, dodecyl bromide per plate) in the plate incorporation test (1st experiment) and the preincubation test (2nd experiment), each without or with metabolic activation.

Results and discussion

Test results

Test results 1

Key result

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Positive controls validity:

valid

Test results 2

Key result

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Positive controls validity:

valid

Test results 3

Key result

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Positive controls validity:

valid

Test results 4

Key result

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Positive controls validity:

valid

Test results 5

Key result

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

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

Dimethylaminopropylmethacrylamide, dodecyl bromide tested up to the top concentration of 100 µg/plate without and with metabolic activation, respectively, caused no mutagenic effect in the Salmonella typhimurium strains TA98, TA100, TA1535 and TA1537 as well as in the Escherichia coli strain WP2 uvrA neither in the plate incorporation test nor in the preincubation test.