2-[2-(3-aminopropoxy)ethoxy]ethanol

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:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with restrictions. (Only 4 test strains used and only 2-Aminoanthracene is used as positive control for S9 mix. No testing for cross-linking using TA102 or WP strains.)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

adopted 21 July 1997

Deviations:

yes

Remarks:

only 4 tester strains used; no testing for crosslinking using TA102 or E.coli WP2 strains; 2-AA sole positive control used for S9 mix

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

2-[2-(3-aminopropoxy)ethoxy]ethanol

EC Number:

203-960-0

EC Name:

2-[2-(3-aminopropoxy)ethoxy]ethanol

Cas Number:

112-33-4

Molecular formula:

C7H17NO3

IUPAC Name:

2-[2-(3-aminopropoxy)ethoxy]ethan-1-ol

Details on test material:

- Name of test material (as cited in study report): 9-Amino-3,6-dioxanonan-1-ol
- Physical state: colorless liquid
- Analytical purity: 99.23 %
- Lot/batch No.: 1/9/3
- Test substance No.: 91/455
- Storage condition of test material: room temperature

Method

Target gene:

his operon

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Additional strain / cell type characteristics:

other: uvrB (all strains), rfa (all strains), R factor plasmid (TA98 + TA100)

Metabolic activation:

with and without

Metabolic activation system:

co-factor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats pretreated for 5 days with 500 mg/kg bw Aroclor 1254

Test concentrations with justification for top dose:

first (standard plate test) and second (preincubation test) experiment:
20, 100, 500, 2500, 5000 µg/plate
with and without metabolic activation

Vehicle / solvent:

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

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

water

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-Aminoanthracene (2-AA, 2.5µg/plate; all +S9); N-methyl-N'-nitro-N-N-nitroso-guanidine (MNNG, 5µg/plate, TA100 & TA 1535, -S9), 4-nitro-o-phenylendiamine chloride monohydrate (NPD, 10µg/plate; TA98 -S9); 9-Aminoacridine (AAC, 100µg/plate; TA1537 -S9)

Remarks:

all positive controls dissolved in DMSO

Details on test system and experimental conditions:

METHOD OF APPLICATION: in medium; with and without preincubation

DURATION
- Preincubation period: 20 minutes
- Exposure duration: 48 hours

NUMBER OF REPLICATIONS: 3 replications in 1 experiment each for standard plate test and preincubation test

DETERMINATION OF CYTOTOXICITY
- Method: reduced background growth and decrease in number of his+ revertants

Evaluation criteria:

In general, a substance to be characterized as positive in the AMES Test has to fulfill the following requirements:
- doubling of the spontaneous mutation rate (control)
- dose-response relationship
- reproducibility of the results

Statistics:

mean values and standard deviations were calculated

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:

in all tester strains depending on strain and test condtions at >2500 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Test results 2

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:

only with TA1537 and TA98 at 5000µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: none observed

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'. Remarks: preincubation test

Any other information on results incl. tables

table1: Test results of experiment I (standard plate test)

With or without S9 mix	Test substance concentration [µg/plate]	Mean number of revertant colonies per plate (average of 3 plates ± standard deviation)
		Basepair substitution type		Frameshift type
		TA100	TA1535	TA98	TA1537
-	0	84 ± 1	12 ± 3	21 ± 3	8 ± 1
-	20	103 ± 10	12 ± 3	21 ± 3	7 ± 1
-	100	95 ± 5	13 ± 3	14 ± 2	9 ± 2
-	500	68 ± 10	12 ± 4	15 ± 3	4 ± 1
-	2500	95 ± 11	11 ± 2	18 ± 5	6 ± 2
-	5000	74 ± 5	13 ± 2	14 ± 3	5 ± 4
Positive controls, -S9	Name   Conc. [µg/plate] Mean no. of col./plate (average of 3 ± SD)	MNNG*   5   880 ± 36	MNNG*   5   740 ± 31	NPD*   10   777 ± 50	AAC*   100   602 ± 58
		TA100	TA1535	TA98	TA1537
+	0	91 ± 9	13 ± 2	24 ± 4	9 ± 3
+	20	92 ± 21	11 ± 3	24 ± 3	7 ± 2
+	100	108 ± 10	14 ±3	23 ± 8	7 ± 2
+	500	109 ± 8	10 ± 2	37 ± 8	5 ± 1
+	2500	113 ± 17	13 ± 4	25 ± 4	4 ± 0
+	5000	89 ± 8	12 ± 2	11 ± 2	5 ± 1
Positive controls, +S9	Name   Conc. [µg/plate] Mean no. of col./plate (average of 3 ± SD)	2-AA*   2.5   1013 ± 21	2-AA*   2.5   93 ± 15	2-AA*   2.5   835 ± 42	2-AA*   2.5   82 ± 7

table2: Test results of experiment II (preincubation test)

With or without S9 mix	Test substance concentration [µg/plate]	Mean number of revertant colonies per plate (average of 3 plates ± standard deviation)
		Basepair substitution type		Frameshift type
		TA100	TA1535	TA98	TA1537
-	0	100 ± 14	16 ± 4	28 ± 5	8 ± 1
-	20	115 ± 11	15 ± 4	18 ± 4	7 ± 0
-	100	122 ± 10	12 ± 3	23 ± 8	6 ± 2
-	500	126 ± 2	17 ± 3	21 ± 7	8 ± 2
-	2500	87 ± 15	8 ± 1	19 ± 1	3 ± 1
-	5000	58 ± 17	5 ± 4	- ± -	- ± -
Positive controls, -S9	Name   Conc. [µg/plate] Mean no. of col./plate (average of 3 ± SD)	MNNG*   5   578 ± 66	MNNG*   5   571 ± 30	NPD*   10   744 ± 38	AAC*   100   412 ± 14
		TA100	TA1535	TA98	TA1537
+	0	107 ± 5	13 ± 3	27 ± 7	12 ± 2
+	20	118 ± 10	14 ± 2	24 ± 4	7 ± 1
+	100	125 ± 16	13 ± 1	27 ± 8	9 ± 3
+	500	110 ± 11	11 ± 2	27 ± 3	10 ± 0
+	2500	105 ± 20	12 ± 3	24 ± 6	6 ± 2
+	5000	104 ± 4	13 ± 3	18 ± 3	5 ± 2
Positive controls, +S9	Name   Conc. [µg/plate] Mean no. of col./plate (average of 3 ± SD)	2-AA*   2.5   561 ± 9	2-AA*   2.5   82 ± 3	2-AA*   2.5   556 ± 39	2-AA*   2.5   78 ± 9

* MNNG - N-methyl-N'-nitro-N-nitroso-guanidine; NPD - 4 -nitro-o-phenylendiamine; AAC - 9 -Aminoacridine chloride monohydrate; 2AA - 2 -Aminoanthracene

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative