Tripropylamine

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: GLP Guideline study (OECD 471), with a deviation (2-AA was used as sole indicator of the efficiancy of the S9-mix

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

2-AA was used as sole indicator of the efficacy of the S9-mix.

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Tripropylamine

EC Number:

203-047-7

EC Name:

Tripropylamine

Cas Number:

102-69-2

Molecular formula:

C9H21N

IUPAC Name:

tripropylamine

Test material form:

other: solution

Details on test material:

- Name of test material (as cited in study report): Tripropylamin
- Physical state: colorless liquid
- Analytical purity: 98.7 g/100 g (GC)
- Lot/batch No.: Behälter 960
- Storage condition of test material: room temperature

Method

Target gene:

his operon, trp operon

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2

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, 5000 µg/plate (S. typhimurium and E. coli)
Preincubation test: 0, 4, 20, 100, 500, 2500 µg/plate (S. typhimurium); 0, 20, 100, 500, 2500, 5000 µg/plate (E. coli).

Vehicle / solvent:

- Vehicle/solvent used: acetone

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

acetone

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
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth

METHOD OF APPLICATION: standard plate test
DURATION
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth

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.
A test substance is generally considered non-mutagenic in this test if: The number of revertants for all tester strains are within the historical negative control range under all experimental conditions in two experiments carried out independently of each other.

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:

Standard plate test: depending on the strain and test conditions from about 2,500 µg/plate onward. Preincubation assay: depending on the strain and test conditions from about 100 µg - 500 µg/plate onward.

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

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:

In the preincubation assay bacteriotoxicity was observed depending on the strain and test conditions from about 2500 µg/plate onward.

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

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	19±1	105±4	112±3	9±1	10±1	24±2	33±3	32±4	31±4
20	18±2	15±1	103±6	108±8	10±1	11±2	21±3	30±1	29±4	30±3
100	14±3	16±2	98±7	108±2	9±1	11±2	18±1	34±3	27±1	32±5
500	15±2	16±3	103±3	117±6	6±2	10±2	19±1	27±6	24±3	34±1
2500	6±3	13±2	100±2	106±8	7±2	7±1	20±1	25±3	24±2	28±3
5000	10±	14±4^X	102±3	94±6^X	7±2	4±2^X	16±2	29±4	25±5	28±7
2 -AA	-	156±1	-	1191±131	-	187±4	-	1823±73	-	199±7
MNNG	848±44	-	1005±8	-	-	-	-	-	-	-
AAC	-	-	-	-	1204±7	-	-	-	-	-
NOPD	-	-	-	-	-	-	698±17	-	-	-
ENNG	-	-	-	-	-	-	-	-	940±50	-

Mean ± SD

Preincubation-test:

Dose (µg/plate)	TA1535		TA100		TA1537		TA98		E. coli WP2 uvrA
	-S9	+S9	-S9	+S9	-S9	+S9	-S9	+S9	-S9	+S9
0	21±1	20±2	115±3	111±9	11±2	11±1	29±2	39±1	28±3	37±6
4	19±0	17±1	110±15	106±10	9±2	10±2	26±3	26±5	-	-
20	18±3	17±3	103±8	112±9	9±2	9±1	20±2	25±6	26±4	27±5
100	17±1	16±3	103±8	108±7	9±2	8±2	18±2	23±2	23±2	22±2
500	15±2	11±2	113±10	105±14	10±1	6±2	17±4	21±2	21±2	19±3
2500	X	X	X	X	X	X	X	X	18±4	16±4
5000	-	-	-	-	-	.-	-	-	X	X
2-AA	-	140±33	-	1039±31	-	150±8	-	973±20	-	210±12
MNNG	1166±47	-	1329±21	-	-	-	-	-	-	-
AAC	-	-	-	-	697±27	-	-	-	-	-
NOPD	-	-	-	-	-	-	677±4	-	-	-
ENNG	-	-	-	-	-	-		-	903±66	-

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

Under the conditions tested Tripropylamine is non mutagenic in the bacterial AMES-test.

The positive controls gave the expected values.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

Tripropylamine was negative in the Standard Plate Test and in the Preincubation Test.

Executive summary:

Tri-n-propylamine was tested for its mutagenic activity in the Salmonella - Escherichia coli/Mammalian-Microsome Reverse Mutation Assay. The tester strains used in the mutagenicity assay were Salmonella typhimurium tester strains TA98, TA100, TA1535, TA1537, and Escherichia coli tester strain WP2uvrA. The assay was conducted with five doses of the test article in the presence and the absence of S9 mix along with concurrent vehicle and positive controls using three plates per dose. The doses tested were 0, 20, 100, 500, 2500, 5000 µg/plate in the standard plate test (Salmonella typhimurium and E. coli) and 0, 4, 20, 100, 500, 2500 µg/plate (Salmonella typhimurium) and 0, 20, 100, 500, 2500, 5000 µg/plate (E. coli) in the preincubation test. The experiments were performed in the presence and absence of S9 mix.

The results show that, under the conditions of this study, tri-n-propylamine did not cause a positive increase in the number of revertants per plate of any of the tester strains either in the presence or absence of microsomal enzymes prepared from Aroclor™-induced rat liver (S9).