Registration Dossier

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

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: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Version / remarks:
adopted 1983
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
2-(2-aminoethylamino)ethanol
EC Number:
203-867-5
EC Name:
2-(2-aminoethylamino)ethanol
Cas Number:
111-41-1
Molecular formula:
C4H12N2O
IUPAC Name:
2-[(2-aminoethyl)amino]ethan-1-ol
Details on test material:
- Name of test material: Aminoethylethanolamin (AEEA), test substance 89/233
- Analytical purity: 99 %
- Storage condition of test material: roóm temperature

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
not applicable
Metabolic activation:
with and without
Metabolic activation system:
microsomal enzyme systems (S-9 fraction) from Aroclor 1254-induced male Sprague-Dawley rat liver
Test concentrations with justification for top dose:
1st experiment: 0, 20, 100, 500, 2500 or 5000 µg/plate
2nd experiment: 0, 2000, 4000, 6000, 8000 µg/plate
Vehicle / solvent:
- solvent used: double distilled water
Controlsopen allclose all
Untreated negative controls:
yes
Remarks:
sterility control
Negative solvent / vehicle controls:
yes
Remarks:
solvent control
True negative controls:
no
Remarks:
with and without S-9 mix , in TA 1535, TA 1537, TA 98 and TA 100
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene (with S-9 mix)
Remarks:
with S-9 mix , in TA 1535, TA 1537, TA 98 and TA 100
Positive controls:
yes
Positive control substance:
N-ethyl-N-nitro-N-nitrosoguanidine
Remarks:
without S-9 mix , in TA 1535, TA 1537, TA 98 and TA 100
Positive controls:
yes
Positive control substance:
other: 4-nitro-phenylendiamine
Remarks:
without S-9 mix , in TA 1535, TA 1537, TA 98 and TA 100
Positive controls:
yes
Positive control substance:
9-aminoacridine
Remarks:
without S-9 mix, in TA 1535, TA 1537, TA 98 and TA 100
Details on test system and experimental conditions:
METHOD OF APPLICATION:
- standard plate and preincubation method

DURATION
- Preincubation period: 20 minutes
- Expression time (cells in growth medium): 48 h

SELECTION AGENT (mutation assays): minimal amino acid solution 0.05 mM histidine + 0.05 mM biotin

NUMBER OF PLATES:
- 3 per dose or control

DETERMINATION OF CYTOTOXICITY
- Method: colonies (his+ revertants) were counted
Evaluation criteria:
Characterization of a substance as positive requires:
- doubling of the spontaneous mutation rate
- dose-response relationship
- reproducibility of the results

Results and discussion

Test results
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
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

AEEA showed no mutagenic response in any strain with or without S-9 mix.
The substance was completely soluble in water. 

Cytotoxicity was only observed in the preincubation test depending on the strain at 2500 and 5000 µg/plate.

Applicant's summary and conclusion

Executive summary:

In a reverse gene mutation assay the bacteria strains TA 1535, TA 1537, TA 98 and TA 100 of S. typhimurium  were exposed to AEEA (99.0 % a.i.) at concentrations of 0, 20, 100, 500, 2000, 2500, 4000, 5000, 6000 or 8000 µg/plate (3 plates/dose) in the presence and absence of mammalian metabolic activation applying both the standard plate and the pre-incubation method (BASF AG, Department of Toxicology, 1991). AEEA was completely soluble in water and tested up to 8000 µg/plate. Cytotoxicity was only observed in the pre-incubation test depending on the strain at 2500 and 5000 µg/plate. The positive controls induced the appropriate responses in the corresponding strains. There was no evidence of induced mutant colonies over background.

This study is classified as acceptable and satisfies the requirement of OECD Test Guideline 471 for in vitro mutagenicity (bacterial reverse gene mutation) data.