2-[2-(dimethylamino)ethoxy]ethanol

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD guideline study (OECD 471/472) conducted in compliance with GLP regulations

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

and OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay) (May 1983/Revised Draft, March 1996)

Deviations:

yes

Remarks:

Compared to OECD TG 471 (1997), only one positive control substance (2AA) used as the sole indicator of the efficacy of the S9-mix, a second control substance is missing.

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

2-[2-dimethylamino)ethoxy]ethanol

IUPAC Name:

2-[2-dimethylamino)ethoxy]ethanol

Constituent 2

Reference substance name:

2-[2-(dimethylamino)ethoxy]ethanol

EC Number:

216-940-1

EC Name:

2-[2-(dimethylamino)ethoxy]ethanol

Cas Number:

1704-62-7

Molecular formula:

C6H15NO2

IUPAC Name:

2-[2-(dimethylamino)ethoxy]ethan-1-ol

Details on test material:

- Name of test material (as cited in study report): Dimethylaminodiglycol
- Physical state: Colorless to yellowish liquid
- Analytical purity: 99.1 area-% (GC)
- Storage condition of test material: Room temperature

Method

Target gene:

His +/-; Trp +/-

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:

The S9 fractions were prepared from the liver of Aroclor 1254-induced male Sprague-Dawley rats.

Test concentrations with justification for top dose:

0; 20; 100; 500; 2500 and 5000 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: water
- Justification for choice of solvent/vehicle: good solubility

Controls

Untreated negative controls:

yes

Remarks:

sterility control

Negative solvent / vehicle controls:

yes

Remarks:

water control

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: With S-9 mix: all strains 2-aminoanthracene; without S-9 mix: strains TA100, TA1535: N-methyl-N'-nitro-N-nitrosoguanidine; TA98: 4-nitro-o-phenylendiamine; TA1537: 9-aminoacridine; E.coli WP2 uvrA: N-ethyl-N'-nitro-N-nitrosoguanidine.

Details on test system and experimental conditions:

METHOD OF APPLICATION: preincubation test

DURATION
- Preincubation period: 20 min
- Exposure duration: 48 h

NUMBER OF REPLICATIONS: 3


METHOD OF APPLICATION: standard plate test (plate incorporation assay)

DURATION
- Exposure duration: 48 h

NUMBER OF REPLICATIONS: 3


DETERMINATION OF CYTOTOXICITY (in both assays)
- Method: Toxicity was detected by a
- decrease in the number of revertants
- clearing or diminution of the background lawn (= reduced his- or trp- background growth)
- reduction in the titer.

Evaluation criteria:

The test chemical is considered positive in this assay if the following criteria are met: A dose-related and reproducible increase in the number of revertant colonies, i.e. about doubling of the spontaneous mutation rate in at least one tester strain either without S-9 mix or after adding a metabolizing system.

Results and discussion

Test results

Test results 1

Species / strain:

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

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

A slight decrease in the number of revertants was occasionally observed depending on the strain and test conditions at doses > 2500 µg/plate.

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

A slight decrease in the number of revertants was occasionally observed at doses of 5000 µg/plate.

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No test substance precipitation was found.

Any other information on results incl. tables

Standard plate test (mean ± SD):

Dose (µg/plate)

TA1535

TA100

TA1537

TA98

E. coli WP2 uvrA

-S9

+S9

-S9

+S9

-S9

+S9

-S9

+S9

-S9

+S9

0

21±2

23±1

117±6

117±3

13±1

16±2

29±2

45±4

32±2

47±3

20

20±1

20±1

113±7

109±7

13±1

12±1

26±2

35±1

32±4

42±4

100

17±2

18±3

107±11

107±3

13±3

11±1

24±3

33±1

32±5

39±2

500

19±3

20±1

109±15

115±19

11±2

9±2

23±2

31±3

34±4

34±1

2500

19±2

19±1

104±10

123±9

11±2

8±1

24±3

28±1

31±3

33±3

5000

6±1

17±3

100±8

115±13

12±1

11±1

22±2

29±2

28±2

36±5

2 -AA

-

149±25

-

1243±212

-

110±5

-

1127±86

-

206±23

MNNG

1048±64

-

1116±75

-

-

-

-

-

-

-

AAC

-

-

-

-

732±64

-

-

-

-

-

NOPD

-

-

-

-

-

-

728±62

-

-

-

ENNG

-

-

-

-

-

-

-

-

749±69

-

Preincubation-test (mean ± SD):

Dose (µg/plate)

TA1535

TA100

TA1537

TA98

E. coli WP2 uvrA

-S9

+S9

-S9

+S9

-S9

+S9

-S9

+S9

-S9

+S9

0

21±2

20±2

129±9

150±17

12±1

13±2

31±1

46±6

33±2

49±5

20

20±3

19±1

121±8

166±12

10±1

10±1

31±1

43±2

32±3

45±5

100

18±3

18±2

123±11

162±11

10±1

11±1

31±3

42±4

31±4

40±2

500

15±2

18±1

117±17

159±13

9±1

8±1

26±3

41±3

26±4

41±3

2500

13±1

16±3

145±16

160±13

9±2

7±2

23±3

31±1

26±7

37±2

5000

9±2

15±2

126±7

163±15

6±1

8±1

24±2

31±1

22±2

31±1

2-AA

-

170±29

-

1593±105

-

135±32

-

1380±205

-

233± 13

MNNG

2029±73

-

2281±169

-

-

-

-

-

-

-

AAC

-

-

-

-

644±58

-

-

-

-

-

NOPD

-

-

-

-

-

-

871±140

-

-

-

ENNG

-

-

-

-

-

-

-

-

764±5

-

X: reduced background growth

2-AA: 2-aminoanthracene

MNNG; N-methyl-N-nitro-N-nitrosoguanidine

ENNG; N-ethyl-N-nitro-N-nitrosoguanidine

NOPD: 4-nitro-o-phenylendiamine

AAC: 9-aminoacridine chloride monohydrate

Under the conditions tested 2-[2-(dimethylamino)ethoxy]ethanol is non mutagenic in the bacterial AMES-test.

The positive control gave the expected response.