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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented report whcih meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2,2-Aminoethoxyethanol
- Analytical purity: 99.6 %
- Other: room temperature

Method

Target gene:
Histidin operon
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
S9-mix from Aroclor 1254 treated male Sprague-Dawley rats.
Test concentrations with justification for top dose:
All tester strains: 0, 20, 100, 500, 2500 and 5000 ug/plate (standard plate test and preincubation test);
TA 98: 12.5, 25, 50 and 100 ug/plate (preincubation test)
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: water
Controls
Untreated negative controls:
yes
Remarks:
water control
Negative solvent / vehicle controls:
yes
Remarks:
sterility 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
Details on test system and experimental conditions:
METHOD OF APPLICATION: preincubation

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

NUMBER OF REPLICATIONS: 3


METHOD OF APPLICATION: standard plate test

DURATION
- Exposure duration: 48 h

NUMBER OF REPLICATIONS: 3
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
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:
in the preincubation test without S-9 mix depending on the strain at doses > 2500 µg/plate.
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: Complete solubility of test substance in aqua dest.
Remarks on result:
other: other: Salmonella typhimurium TA1535, TA100, TA1537, TA98
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Standart plate test:

 Dose (µg/plate)  TA1535     TA100     TA1537     TA98                                                 
   -S9  +S9  -S9  +S9  -S9  +S9 -S9  +S9                                              
 0

19±4

16±2

95±10

104±11

9±1

12±3

24±5

30±2

 

 

 

 

 

 

                                 

20 

15±6

11±6

103±13

107±7

10±3

14±4

23±4

33±2

 

 

 

 

 

 

                                 

 100

18±6

17±2

103±12

105±3

7±2

13±1

22±2

33±3

 

 

 

 

 

 

                                 

 500

14±5

17±5

93±21

99±9

13±2

18±2

17±2

36±6

 

 

 

 

 

 

                                 

 2500

16±6

20±1

102±4

92±10

9±3

14±2

20±4

37±4

 

 

 

 

 

 

                                 

5000

14±4

21±2

90±11

107±7

14±6

18±3

21±1

30±2

 

 

 

 

 

 

                                 

2AA

-

215±10

-

1029±22

-

180±17

-

1003±61

 

 

 

 

 

 

                                 

MNNG

1332±112

-

1373±90

-

-

-

-

-

 

 

 

 

 

 

                                 

AAC

-

-

-

-

354±56

-

-

-

 

 

 

 

 

 

                                 

NOPD

-

-

-

-

-

-

861±14

-

 

 

 

 

 

 

                                 

Mean ± SD

Preincubation-test:

 Dose (µg/plate)  TA1535     TA100     TA1537     TA98                                                 
   -S9  +S9  -S9  +S9  -S9  +S9 -S9  +S9                                              
 0

12±2

12±1

82±4

100±9

7±2

11±2

20±2

37±4

 

 

 

 

 

 

                                 

20 

12±4

14±2

76±3

93±16

8±3

13±3

18±6

60±2

 

 

 

 

 

 

                                 

 100

11±4

13±1

79±3

107±9

6±4

15±1

24±5

46±5

 

 

 

 

 

 

                                 

 500

13±6

11±4

87±2

88±10

5±2

13±2

27±1

53±8

 

 

 

 

 

 

                                 

 2500

16±3

14±2

61±2

86±5

7±3

10±3

21±9

49±8

 

 

 

 

 

 

                                 

5000

10±8

16±3

42±12

81±6

x

15±5

14±2

34±3

 

 

 

 

 

 

                                 

2AA

-

271±15

-

1415±74

-

113±26

-

1330±95

 

 

 

 

 

 

                                 

MNNG

1310±216

-

1335±88

-

-

-

-

-

 

 

 

 

 

 

                                 

AAC

-

-

-

-

426±96

-

-

-

 

 

 

 

 

 

                                 

NOPD

-

-

-

-

-

-

804±62

-

 

 

 

 

 

 

                                 

Mean ± SD

Preincubation-test:

 Dose (µg/plate)  TA98                                               
   -S9  +S9                                              
 0

26±4

34±2

 

 

 

 

 

 

                                 

12.5

22±2

35±4

 

 

 

 

 

 

                                 

 25

20±6

36±3

 

 

 

 

 

 

                                 

50

28±2

33±2

 

 

 

 

 

 

                                 

100

26±3

33±2

 

 

 

 

 

 

                                 

2AA

-

753±8

 

 

 

 

 

 

                                 

NOPD

844±33

-

 

 

 

 

 

 

                                 

Mean ± SD

X: reduced background growth

2-AA: 2-aminoanthracene;

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

NOPD: 4-nitro-o-phenylendiamine

AAC: 9-aminoacridine chloride monohydrate

Under the conditions tested 2-(2-aminoethoxy)ethanol in non mutagenic in the bacterial AMES-test.

The positive controls gave the expected values.

Applicant's summary and conclusion