Isopentylamine

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:

16. Nov 1997 - 26. Nov 1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study (OECD471).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Isopentylamine

EC Number:

203-526-0

EC Name:

Isopentylamine

Cas Number:

107-85-7

Molecular formula:

C5H13N

IUPAC Name:

isopentylamine

Details on test material:

- Name of test material (as cited in study report): Isopentylamin
- Physical state: Colorless liquid
- Analytical purity: 99.1 area % (GC)
- Lot/batch No.: V. 1066-C Fr. 7+8+9
- Storage condition of test material: Room temperature (N2 conditions)

Method

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:

standard plate test: 0; 20; 100; 500; 2500 and 5000 µg/plate (with and without S9-mix).
preincubation test I.: 0; 4; 20; 100; 500 and 2500 µg/plate (with and without S9-mix).
preincubation test II. 0; 0.4; 2; 10; 50 and 150 µg/plate (without S9-mix).

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: water

Controls

Untreated negative controls:

yes

Remarks:

sterility control

Negative solvent / vehicle controls:

yes

Remarks:

water control

True negative controls:

not specified

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

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:

Standard plate test: depending on the strain and test conditions from about 2500 µg/plate onward. Preincubation assay: depending on the strain and test conditions from about 20 µg/plate onward.

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.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Standart plate test:

Dose (µg/plate)

TA1535

TA100

TA1537

TA98

E. coli WP2 uvrA

-S9

+S9

-S9

+S9

-S9

+S9

-S9

+S9

-S9

+S9

0

19±1

20±2

97±6

112±7

10±1

11±2

26±1

35±4

25±2

35±2

20

18±2

20±1

98±10

114±20

10±2

11±2

25±3

31±1

35±4

43±2

100

18±2

16±3

113±12

103±21

11±2

11±1

24±1

37±3

43±5

43±2

500

20±3

21±4

105±12

105±14

10±2

11±1

22±1

32±2

41±6

45±2

2500

9±1

14±6

102±8

129±5

5±1

10±0

14±4

29±7

35±2

42±1

5000

x

x

37±7x

68±11x

x

x

x

x

25±1x

24±4x

2 -AA

-

195±9

-

1528±22

-

193±11

-

1172±154

-

227±22

MNNG

749±46

-

1032±60

-

-

-

-

-

-

-

AAC

-

-

-

-

789±64

-

-

-

-

-

NOPD

-

-

-

-

-

-

756±45

-

-

-

ENNG

-

-

-

-

-

-

-

-

746±51

-

Mean ± SD

Preincubation-test 1.:

Dose (µg/plate)

TA1535

TA100

TA1537

TA98

E. coli WP2 uvrA

-S9

+S9

-S9

+S9

-S9

+S9

-S9

+S9

-S9

+S9

0

20±2

17±2

107±7

116±11

11±2

13±2

29±3

38±11

43±8

36±4

4

15±3

17±4

75±4

107±18

8±3

9±1

25±3

45±1

38±2

33±6

20

11±3x

13±4x

48±5x

112±9x

4±1x

6±2x

13±3x

38±2x

30±3

23±5

100

8±3x

10±3x

26±6x

60±9x

3±1x

6±3x

10±1x

34±4x

25±2x

22±3x

500

x

11±4x

x

46±3x

x

5±1x

x

27±8x

16±2x

24±2x

2500

x

5±1x

x

20±4x

x

x

x

19±3x

12±1x

24±1x

2-AA

-

246±22

-

987±82

-

150±21

-

627±27

-

284±62

MNNG

855±82

-

1148±83

-

-

-

-

-

-

-

AAC

-

-

-

-

528±94

-

-

-

-

-

NOPD

-

-

-

-

-

-

531±29

-

-

-

ENNG

-

-

-

-

-

-

-

-

799±11

-

Mean ± SD

Preincubation-test 2.:

Dose (µg/plate)

TA1535

TA100

TA1537

TA98

-S9

-S9

-S9

-S9

0

18±1

107±4

11±1

30±2

0.4

16±3

101±8

9±2

24±3

2

15±2

103±5

9±1

28±3

10

17±1

101±4

7±1

22±4

50

14±1

100±3

9±1

22±3

150

11±2

102±5

7±1

19±1

MNNG

1157±54

1023±18

-

-

AAC

-

-

678±27

-

NOPD

-

-

-

949±12

Mean ± SD

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

According to the results of the study the test substance Isopentylamine

is not mutagenic in the AMES test and in the Escherichia coli - reverse

mutation assay under the experimental conditions chosen here.

The positive controls gave the expected values.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

Executive summary:

Isopentylamine was tested for its potential to induce mutations in bacteria in vitro with and without metabolic activation according to OECD TG 471 and under GLP conditions. The test strains included S. typhimurium TA1535, TA1537, TA98, TA100, and E. coli WP2 uvr A. The test concentrations were 0; 20; 100; 500; 2500 and 5000 µg/plate (with and without S9-mix) in the standard plate test. Concentrations in preincubation tests were 0; 4; 20; 100; 500 and 2500 µg/plate (with and without S9-mix) in the first and 0, 0.4, 2, 10, 50 and 150 µg/plate (without metabolic activation) in the second preincubation test.

Isopentylamine was not mutagenic in any strain. No precipitation was noted. Cytotoxicity was seen from 2500 µg/plate onwards in the standard plate test, and from 20 µg/plate onwards in the preincubation tests. Negative and positive controls performed as expected. This test is considered to be valid for assessment, and it is concluded that isopentylamine is not mutagenic in bacteria (BASF, 1999).