3-[(2-hydroxyethyl)amino]propanol

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other: GLP compliant, guideline study, available as unpublished report no restrictions, fully adequate for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Test guideline 3

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

3-[(2-hydroxyethyl)amino]propanol

EC Number:

242-978-3

EC Name:

3-[(2-hydroxyethyl)amino]propanol

Cas Number:

19344-29-7

Molecular formula:

C5H13NO2

IUPAC Name:

3-[(2-hydroxyethyl)amino]propan-1-ol

Details on test material:

- Name of the test substance used in the study report: 3-(2-Hydroxyethylamino)-1-propanol
- Physical state: Colorless to yellowish liquid
- Storage condition of test material: Room temperature
- Analytical purity: 99.3%
- Lot/batch No.: Abl. Nr. 61-1853

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:

Aroclor induced rat liver S-9 mix

Test concentrations with justification for top dose:

0; 20; 100; 500; 2,500 and 5,000 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: water (standard plate test) and DMSO (preincubation test)

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

N-ethyl-N-nitro-N-nitrosoguanidine

other: 2-aminoanthracene, N-methyl-N'-nitro-N-nitrosoguanidine, 4-nitro-o-phenylendiamine

Remarks:

With metabolic activation (all strains): 2-aminoanthracene. Without metabolic activation: N-methyl-N'-nitro-N-nitrosoguanidine (TA 100, TA 1535); 4-nitro-o-phenylendiamine (TA 98); 9-aminoacridine (TA 1537); N-ethyl-N'-nitro-N-nitrosoguanidin (E. Coli)

Details on test system and experimental conditions:

METHOD OF APPLICATION: Standard Plate Test and Preincubation Test

DURATION
- Preincubation period: 20 minutes (Preincubation Test only)
- Exposure duration: for 48 - 72 hours

NUMBER OF REPLICATIONS: 3 plates per dose and per control

DETERMINATION OF CYTOTOXICITY
- Method: Reduced titer, reduced his or trp background growth, decrease in the number of his- or trp- revertants was determined.

Evaluation criteria:

A substance to be characterized 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.

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:

>= 2500 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

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:

>= 2500 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

- Mutagenicity tests: An increase in the number of his+ or trp+ revertants was not observed both in the standard plate test and in the preincubation test either without S-9 mix or after the addition of a metabolizing system.
- Toxicity: A bacteriotoxic effect (reduced titer, reduced his- or trp- background growth, decrease in the number of his+ or trp+ revertants) was observed depending on the strain and test conditions at doses ≥ 2,500 µg/plate.
- Solubility: No test substance precipitation was found.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative