(3-methacrylamidopropyl)trimethylammonium 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

Study period:

2006-12-06 to 2006-12-21

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study. GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

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:

dated May 19, 2000

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

adopted 21 July 1997

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:

(3-methacrylamidopropyl)trimethylammonium chloride

EC Number:

257-182-1

EC Name:

(3-methacrylamidopropyl)trimethylammonium chloride

Cas Number:

51410-72-1

Molecular formula:

C10 H21 N2 O. Cl

IUPAC Name:

trimethyl-[3-(2-methylprop-2-enoylamino)propyl]azanium chloride

Test material form:

other: aqueous solution

Details on test material:

- Name of test material (as cited in study report): Trimethylammoniumpropyl methacrylamide chloride

Method

Target gene:

his

Species / strain

Species / strain / cell type:

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

Details on mammalian cell type (if applicable):

not applicable

Metabolic activation:

with and without

Metabolic activation system:

S9 mix

Test concentrations with justification for top dose:

0.0316, 0.100, 0.316, 1.0, 2.5, 5 µL/plate (maximum spacing 3.16)

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: distilled water
- Justification for choice of solvent/vehicle: compatible with survival of bacteria and S9 activity

Controls

Controls 1

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

sodium azide

methylmethanesulfonate

other: 4-nitro-o-phenylene-diamine (without metabolic activation)

Controls 2

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene (with metabolic activation)

Details on test system and experimental conditions:

METHOD OF APPLICATION: plate incorporation / preincubation

DURATION
- Preincubation period: 60 min at 37°C
- Exposure duration: 48 h

NUMBER OF REPLICATIONS: 3

NUMBER OF CELLS EVALUATED: colony count/plate

DETERMINATION OF CYTOTOXICITY
- Method: colony count

MUTATION FACTOR = (mean revertants; test item) / (mean revertants; solvent control)

Evaluation criteria:

- colony count for spontaneous revertants on control plates without metabolic activation within historical range:
TA 98: 18 – 63
TA 100: 79 – 197
TA 1535: 5 – 30
TA 1537: 4 – 32
TA 102: 173 – 396
- positive controls show distinct enhancement of revertant rates over control plates

A test item is considered mutagenic if:
- a clear an d dose-related increase in revertant number occurs
- a biologically relevant positive response for at least one dose group occurs: in TA 100 and TA 102 number of revertants at least twice as high as in solvent control; TA 98, TA 1535, TA 1537 at least three times higher number of revertants as in solvent control

Statistics:

not regarded necessary

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:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: no precipitation observed

COMPARISON WITH HISTORICAL CONTROL DATA: the number of spontaneous revertants was in the range of historical data for all strains

ADDITIONAL INFORMATION ON CYTOTOXICITY: no toxicity observed

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative with and without metabolic activation

MAPTAC (50% in water) was investigated for its potential to induce gene mutations in Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102 according to the plate incorporation test and the pre-incubation test in concentrations of 0.0316, 0.100, 0.316, 1.0, 2.5, 5 µL/plate.
No biologically relevant, dose-dependent increase in revertant numbers were observed in any tester strain at any concentration tested with and without metabolic activation.
MAPTAC is considered to be non-mutagenic in this bacterial reverse mutation assay.

Executive summary:

In a reverse gene mutation assay in bacteria according to OECD guideline 471, adopted 21 July 1997 and EU Method B.13/14, dated 19 May 2000, TA 98, TA 100, TA 1535, TA 1537, TA 102 strains of S. typhimurium were exposed to MAPTAC (50% in water) at concentrations of 0.0316, 0.100, 0.316, 1.0, 2.5, 5 µL/plate in the presence and absence of mammalian metabolic activation. The test was performed as plate incorporation test and as pre-incubation test.

Up to and including the highest concentration tested of 5 µL MAPTAC/plate, no signs of toxicity were observed. There was no evidence of induced mutant colonies over background.

The positive controls induced the appropriate responses in the corresponding strains.

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