[2-(acryloyloxy)ethyl]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:

1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well documented report of a guideline study conducted to GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

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:

[2-(acryloyloxy)ethyl]trimethylammonium chloride

EC Number:

256-176-6

EC Name:

[2-(acryloyloxy)ethyl]trimethylammonium chloride

Cas Number:

44992-01-0

Molecular formula:

C8H16NO2.Cl

IUPAC Name:

Trimethyl[2-(prop-2-enoyloxy)ethyl]azanium chloride

Details on test material:

- Name of test material (as cited in study report): ADAMQUAT MC 80
- Source: Atochem
- Lot/batch No.: 235bis
- Other: supplied as an 80% aqueous solution
- Purity: 98.9 %
- Physical state: liquid
- Viscosity: 41 cPo at 35 °C
- Specific gravity: 1.135 at 20°C
- Melting Point: - 25°C
- Boiling point: 100°C at 760 mmHg
- Solubility: freely soluble in water
- Impurities: residual raw material (dimethylaminoethylacrylate): 1.1 %
- Composition of test material, percentage of components: ADAMQUAT MC 80.3 % and water 19.45 %
- Purity test date: 28-01-1991
- Expiration date of the lot/batch: until June 1991 under the specified storage conditions
- Storage condition of test material: 4°C in the dark

Method

Target gene:

Histidine operon

Species / strain

Species / strain / cell type:

S. typhimurium, other:

Details on mammalian cell type (if applicable):

Strains supplied by B.N. Ame's Test Laboratory (Univerisity of California, Berkley, USA)

STRAINS Histidine Mutations Additional Mutations
TA 1535 His G46 rfa uvrB
TA100 HIS G46 rfa uvrB Factor R
TA1537 HIS C3076 rfa uvrB
TA1538 HIS D3052 rfa uvrB
TA98 HIS D3052 rfa uvrB Factor R

The TA1535 and TA100 strains were reverted to histidine independence by mutagens that cause base-pair substitutions; the TA1537, the TA1538 and TA98 strains were reverted by frameshift mutagens.

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

S9-mix

Test concentrations with justification for top dose:

0, 100, 500, 1000, 2500 and 5000 µg/plate

Vehicle / solvent:

- Vehicle/solvent used: distilled water

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

distilled water

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: Without S9-mix: Sodium Azide; 9-amino acridine; 2-nitrofluorene; WITH S9-mix: 2 anthramine

Remarks:

Solvent Dimethylsulfoxide

Details on test system and experimental conditions:

ADMINISTRATION:
- Number of replicates: 3
- Metabolic activation: S9-mix (from livers of male IOPS-OFA rats treated by Aroclor 1254)
- Vehicle: distilled water
- Negative control: vehicle
- Positive controls: vehicule DMSO
- without S9-mix
- for TA1535 and TA100: sodium azide (1 µg/plate)
- for TA1537: 9-aminoacridine (50 µg/plate)
- for TA1538 and TA98: 2-nitrofluorene (0.5 µg/plate)
- with S9-mix
- for TA1535 and TA1537: 2-anthramine (2 µg/plate)
- for TA1538, TA98 and TA100: 2-anthramine (1 µg/plate)
Type: Ames test
DURATION
- Preincubation period: No
- Exposure duration: 72 hours
- Expression time: revertants per plate
- Incubation temperature: 37°C
EXAMINATION:
- Bacterial toxicity: determined by examination of background lawn growth in a preliminary study with TA98 and TA100.

Evaluation criteria:

CRITERIA FOR EVALUATING RESULTS:
Result is considered as positive when the following criteria are observed:
- dose-related increase in revertant colony count
- the number of revertant colonies per plate with the test substance is more than twice that of negative control.
- reproducibility of results

ANALYTICAL DEVICE:
No data

Statistics:

no data

Results and discussion

Test results

Species / strain:

S. typhimurium, other: TA 1535, TA 1537, TA 1538, TA 98 and TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Remarks:

No toxicity was observed in TA98 and TA100 in the preliminary test.

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

No significant increase in the number of revertants was observed either with or without metabolic activation.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Salmonella Mutagenicity Test – S9
Conc. (mg/plate)	TA 1535	TA1537	TA1538	TA98	TA100
RS	10	7	16	24	102
0	11	7	16	18	109
100	13	5	15	19	101
500	9	5	17	20	100
1000	9	8	17	19	100
2000	6	7	25	18	112
5000	8	6	18	15	96
Pos. Control	319^1	134^2	221^3	137^4	404^5
1.    NaN3 1mg/plate 2.    9-AA 50mg/plate 3.    2-NF 0.5mg/plate 4.    2-NF 0.5mg/plate 5.    5. NaN3 1mg/plate
Salmonella Mutagenicity Test + S9
Conc. (mg/plate)	TA 1535	TA1537	TA1538	TA98	TA100
0	10	5	15	25	111
1000	12	7	16	26	94
500	10	7	15	23	107
1000	11	4	16	21	100
2000	10	5	17	21	99
5000	7	6	16	15	98
Pos. Control	118^6	307^6	1718^7	1686^7	2611^7
6.    2-AM 2mg/plate 7.    2-AM 1mg/plate

 

RS: spontaneous revertants

0: Solvent control (distilled water)

Applicant's summary and conclusion

Conclusions:

Under the experimental conditions, the test substance ACRYLOXYETHYLTRIMETHYLAMMONIUM CHLORIDE (80 % solution in water) (ADAMQUAT MC) is not positive in the Ames test.