2-butylaminoethanol

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.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

; OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)

Deviations:

yes

Remarks:

(2-aminoanthracene was uased as sole indicator of the efficacy of S9-mix)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

2-butylaminoethanol

EC Number:

203-904-5

EC Name:

2-butylaminoethanol

Cas Number:

111-75-1

Molecular formula:

C6H15NO

IUPAC Name:

2-(butylamino)ethan-1-ol

Details on test material:

- Name of test material (as cited in study report): N-Butylethanolamin
- Physical state: colorless to yellowish liquid
- Storage condition of test material: room temperature

Method

Target gene:

His- and 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:

Aroclor-induced rat liver S9-mix

Test concentrations with justification for top dose:

20, 100, 500, 2500, 5000 µg/plate

Vehicle / solvent:

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

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

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 - 72 h at 37°C

NUMBER OF REPLICATIONS: 3

METHOD OF APPLICATION: standard plate test

DURATION
- Exposure duration: 48 - 72 h at 37°C

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

Results and discussion

Test results

Species / strain:

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

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

other: A bacteriotoxic effect was observed in the plate incorporation test depending on the 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:

SOLUBILITY: No precipitation of the test substance was found.

Remarks on result:

other: all strains/cell types tested

Any other information on results incl. tables

Standard plate test:

Dose (µg/plate)	TA1535		TA100		TA1537		TA98		E coli. WP2 uvrA
	-S9	+S9	-S9	+S9	-S9	+S9	-S9	+S9	-S9	+S9
0	20 ± 1	21 ± 2	136 ± 4	153 ± 7	14 ± 1	13 ± 2	37 ± 4	46 ± 1	36 ± 1	41 ± 4
20	27 ± 1	21 ± 1	135 ± 18	169 ± 12	12 ± 3	11 ± 2	25 ± 1	42 ± 2	32 ± 1	42 ± 3
100	22 ± 1	20 ± 3	147 ± 22	136 ± 15	10 ± 2	14 ± 2	23 ± 1	44 ± 4	33 ± 3	45 ± 3
500	27 ± 4	19 ± 4	168 ± 15	183 ± 11	18 ± 1	14 ± 2	26 ± 6	41 ± 3	35 ± 3	37 ± 1
2500	28 ± 3	23 ± 6	169 ± 13	189 ± 4	12 ± 1	13 ± 1	28 ± 1	36 ± 6	33 ± 7	42 ± 5
5000	25 ± 6	26 ± 6	165 ± 9	162 ± 10	13 ± 3	13 ± 4	24 ± 3	21 ± 2	26 ± 6	40 ± 1
2-AA	-	219 ±16	-	1276 ± 53	-	220 ± 21	-	1284 ± 216	-	352 ± 67
MNNG	1093 ± 35	-	1063 ± 59	-	-	-	-	-	-	-
AAC	-	-	-	-	648 ± 53	-	-	-	-	-
NPD	-	-	-	-	-	-	809 ± 76	-	-	-
ENNG	-	-	-	-	-	-	-	-	668 ± 30	-

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	17 ± 1	15 ± 1	106 ± 11	109 ± 9	10 ± 1	10 ± 2	30 ± 2	41 ± 3	31 ± 2	38 ± 3
20	17 ± 2	18 ± 2	109 ± 4	111 ± 20	10 ± 2	9 ± 1	28 ± 5	36 ± 5	32 ± 6	33 ± 3
100	17 ± 1	17 ± 1	115 ± 2	102 ± 11	9 ± 1	9 ± 2	28 ± 1	40 ± 2	30 ± 3	39 ± 7
500	17 ± 3	19 ± 2	106 ± 5	97 ± 4	6 ± 1	8 ± 1	28 ± 3	45 ± 3	31 ± 2	35 ± 3
2500	7 ± 2	17 ± 1	15 ± 3	97 ± 17	4 ± 2	7 ± 1	4 ± 5	40 ± 3	21 ± 4	26 ± 5
5000	-	9 ± 1	-	68 ± 13	-	5 ± 2	-	28 ± 3	-	14 ± 2
2-AA	-	229 ± 8	-	753 ± 39	-	136 ± 8	-	919 ± 79	-	211 ± 6
MNNG	1067 ± 61	-	1137 ± 21	-	-	-	-	-	-	-
AAC	-	-	-	-	694 ± 27	-	-	-	-	-
NPD	-	-	-	-	-	-	1013 ± 25	-	-	-
ENNG	-	-	-	-	-	-	-	-	504 ± 5	-

Mean ± SD

2-AA: 2-aminoanthracene (2.5 µg/p1ate, strains: TA 1535, TA 100, TA 1537, TA 98; 60 µg/p1ate, strain: Escherichia coli WP2 uvrA)

MNNG; N-methyl-N-nitro-N-nitrosoguanidine (5 µg/p1ate, strains: TA 1535, TA 100)

ENNG; N-ethyl-N-nitro-N-nitrosoguanidine (10 µg/p1ate, strain: E. coli WP2 uvrA)

NPD: 4-nitro-o-phenylendiamine (10 µg/p1ate, strain: TA 98)

AAC: 9-aminoacridine chloride monohydrate (100 µg/plate, strain: TA 1537)

Applicant's summary and conclusion

Conclusions:

Interpretation of results: negative
Under the conditions tested butylethanolamine is non mutagenic in the bacterial AMES-test with or without metabolic activation.

Executive summary:

In a reverse gene mutation assay in bacteria (BASF, 1997), strains [TA 1535, TA 1537, TA 98, TA 100] of S. typhimurium and E. coli [E. coli WP2] were exposed to the test substance dissolved in water at concentrations of 20, 100, 500, 2500, 5000 µg/plate in the absence of mammalian metabolic activation and in the presence of Aroclor 1254-induced rat liver S9 mix, respectively (the preincubation method and the standard plate test was used). A bacteriotoxic effect was observed in the plate incorporation test depending on the test conditions from about 2500 µg/plate onward.No significant increase in mutant frequency was observed, either with or without metabolic activation. The positive controls induced the appropriate responses in the corresponding strains.