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Toxicological information

Genetic toxicity: in vitro

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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

Constituent 1
Chemical structure
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

3191

1342

2213

1374

4045

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

1186

3076

17187

16867

26117

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.