2-morpholinoethanol

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:

1996-06-27 to 1998-04-21

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

Version / remarks:

Directive 92/69/EEC

Deviations:

no

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

2-morpholinoethanol

EC Number:

210-734-5

EC Name:

2-morpholinoethanol

Cas Number:

622-40-2

Molecular formula:

C6H13NO2

IUPAC Name:

2-(morpholin-4-yl)ethan-1-ol

Method

Species / strain

Species / strain 1

Species / strain / cell type:

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

Additional strain / cell type characteristics:

not specified

Species / strain 2

Species / strain / cell type:

E. coli WP2 uvr A

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

S9 mix (Aroclor 1254 induced rat liver)

Test concentrations with justification for top dose:

Experiment 1 and 3 (all strains, plate incorporation and preincubation test)
0 ; 20 ; 100 ; 500 ; 2500 and 5000 µg/plate
Experiment 2 (TA 100, plate incorporation)
0; 2000 ; 4000 ; 6000 and 8000 µg/plate
Experiment 2 (E. coli WP2 uvrA, plate incorporation)
0 ; 20 ; 100 ; 500 ; 2500 and 5000 µg/plate

Vehicle / solvent:

- Vehicle used: water
- Justification for choice of solvent/vehicle: Standard vehicle

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: without S9 mix: N-methyl-N'-nitro-N-nitrosoguanidine (TA100, TA1535), 4-nitro-o-phenylendiamine (TA98), 9-aminoacridine (TA1537), N-ethyl-N'-nitro-N-nitrosoguanidin (WP2 uvrA); with S9 mix: 2-aminoanthracene (all strains)

Details on test system and experimental conditions:

1) METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48-72 h at 37°C in the dark
NUMBER OF REPLICATIONS: 3

2) METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 20 min at 37°C
- Exposure duration: 48-72 h at 37°C in the dark
NUMBER OF REPLICATIONS: 3

Evaluation criteria:

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

Statistics:

not required

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:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

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:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

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.

ADDITIONAL INFORMATION ON CYTOTOXICITY:
No bacteriotoxic effect (reduced his- or trp- background growth, decrease in the number of his+ or trp+ revertants) was observed .

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.