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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 study report which meets basic scientific principles.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1987

Materials and methods

Principles of method if other than guideline:
Method: other: according to Haworth et al., Environ. Mutagen., 5 (Suppl. 1), 3-142
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
1-aminopropan-2-ol
EC Number:
201-162-7
EC Name:
1-aminopropan-2-ol
Cas Number:
78-96-6
Molecular formula:
C3H9NO
IUPAC Name:
1-aminopropan-2-ol
Details on test material:
- Name of test material (as cited in study report): Mono-isopropanolamine
- Analytical purity: 96.4%
- Supplier: Aldrich

Method

Target gene:
Strain Target Gene:
TA1537 hisC3076
TA1535 hisG46
TA100 hisG46
TA98 hisD3052
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:
The S9 fractions were prepared from the liver of Aroclor 1254-induced male Sprague-Dawley rats and male Syrian hamsters.
Test concentrations with justification for top dose:
33 - 4000 ug/plate
Vehicle / solvent:
water
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: see remarks
Remarks:
For strains tested in the absence of S9: TA98, 2-nitrofluorene, TA100 and TA1535, sodium azide, TA1537, 9-aminoacridine. For strains tested with S9: All strains, 2-aminoanthracene.
Details on test system and experimental conditions:
METHOD OF APPLICATION: preincubation

DURATION
- Preincubation period: 20 min
- Exposure duration: 2 days
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 h
Evaluation criteria:
According to Haworth et al. (1983).

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium, other: TA98, TA100, TA1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
Slightly toxic at highest dose in the 3 strains.
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
Slightly toxic at highest dose
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with
Genotoxicity:
ambiguous
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
Slightly toxic at highest dose
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
valid

Any other information on results incl. tables

Strain TA100

Dose

No Activation
(Negative)

10% HLI
(Negative)

10% RLI
(Negative)

Dose units

Mean

± SEM

Mean

± SEM

Mean

± SEM

0         

135

2

141

6.8

139

5.6

33         

152

4

144

8.7

132

14.4

100         

141

3.8

140

12.2

138

5.8

333         

148

4.2

140

5.5

149

11.1

1000         

155

0.9

128

6.4

124

4.3

3333         

130S

7.8

159S

7

156S

6.5

Positive Control

1298

63.2

1452

83.5

947

33.3

Strain TA98

Dose

No Activation
(Negative)

10% HLI
(Negative)

10% RLI
(Negative)

Dose units

Mean

± SEM

Mean

± SEM

Mean

± SEM

0         

18

2

30

0.6

24

1.2

33         

19

2.6

36

1.5

25

4.4

100         

25

2.9

43

1.9

30

6.3

333         

17

2.3

25

2.1

33

0.7

1000         

21

3.3

31

4.5

26

4.1

3333         

8T

3.5

20S

4.3

20S

1.8

Positive Control

1475

103.9

935

33.9

637

42.8

Strain TA1537

Dose

No Activation
(Negative)

10% HLI
(Negative)

10% RLI
(Negative)

Dose units

Mean

± SEM

Mean

± SEM

Mean

± SEM

0         

8

1.7

10

1.7

8

0.9

33         

7

2.9

12

1.5

11

2.9

100         

7

0.3

13

1.7

9

0.9

333         

6

1.8

7

1.2

7

1

1000         

6

0.6

7

1.3

8

0.3

3333         

4S

1.2

4S

0.3

5S

0.3

Positive Control

87

12.3

124

6.1

97

2.9

Strain TA1535:

Dose

No Activation
(Negative)

No Activation
(Negative)

No Activation
(Negative)

No Activation
(Negative)

10% HLI
(Equivocal)

10% HLI
(Weak Positive)

10% HLI
(Negative)

10% HLI
(Positive)

10% RLI
(Negative)

10% RLI
(Positive)

10% RLI
(Negative)

10% RLI
(Positive)

Dose units

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

0         

27

5

54

6.4

7

1.2

36

3.6

9

0.9

11

3.2

9

2.5

5

1

9

1.5

9

0.7

7

1.5

11

0

33         

30

1.5

 

 

 

 

 

 

11

2.2

 

 

 

 

 

 

7

2.6

 

 

 

 

 

 

100         

30

4.4

51

4.2

7

0.9

34

0.9

11

1

9

1

8

1.2

10

2.3

11

1.2

10

0.6

7

1.9

11

1.3

333         

27

4.4

45

2.2

6

1.5

32

5

14

0.9

14

1.2

6

0.7

11

2

9

0.9

14

2.8

6

0.7

7

0.3

1000         

20

1.5

47

3.8

4

0.7

23

4.8

10

1.2

9

0.3

7

1.3

11

4.2

7

1.8

14

0.7

5

1.5

9

0.7

1800         

 

 

34

3.8

5

1.3

28

1.3

 

 

24

1.9

10

1.3

29

0.7

 

 

15

1.9

5

1.7

13

3.2

2800         

 

 

25S

0.9

4S

1

23S

2

 

 

30S

2.9

5

0.6

28

6.6

 

 

33S

4.3

8

2

32

2.1

3333         

12S

3.8

25S

4.5

4S

0.9

16S

3.2

27S

1.7

20S

1.8

8S

2.1

24S

2.7

17S

2.5

32S

2.6

6S

2.2

32S

2.2

3500         

 

 

16S

0.6

3S

0.6

21S

0.3

 

 

18S

2.7

6S

1.5

25S

4.7

 

 

20S

1.5

6S

1

26S

2.2

4000         

 

 

13S

1.7

2S

0.6

17S

2.1

 

 

21S

0.9

3S

0.3

15S

2.4

 

 

26S

5.1

4S

1.7

23S

3.3

Positive Control

1005

61

1484

111

869

23.8

1124

41.3

124

3.5

99

2.3

85

2.3

231

16.1

98

6.4

95

11.4

83

4.7

103

13.6

Abbreviations:
RLI = induced male Sprague Dawley rat liver S9
HLI = induced male Syrian hamster liver S9
s = Slight Toxicity; p = Precipitate; x = Slight Toxicity and Precipitate; T = Toxic; c = Contamination

Applicant's summary and conclusion

Conclusions:
Interpretation of results: ambiguous with metabolic activation

Under the conditions tested the test substance was not mutagenic in the strains TA98, TA100 and TA1537.
However, with S9-activation the TA1535 strain presented some weak positive results. Therefore the test substance was rated as ambiguous.