Registration Dossier

Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
Peer reviewed article

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
test concentrations only up to 2000 µg/plate
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

1
Chemical structure
Reference substance name:
2-aminoethanol
EC Number:
205-483-3
EC Name:
2-aminoethanol
Cas Number:
141-43-5
Molecular formula:
C2H7NO
IUPAC Name:
2-aminoethanol
Specific details on test material used for the study:
- Name of test material (as cited in journal article): Monoethanolamine
- Analytical purity: no data
- Batch No.: 17589

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium, other: TA 1535, TA 1537, TA1538, TA 98 and TA 100
Details on mammalian cell type (if applicable):
- Source: obtained from Professor B.N. Ames, University of California
Species / strain / cell type:
E. coli, other: WP2 an WP2 uvrA
Details on mammalian cell type (if applicable):
- Source: obtained from Dr. M.H.L. Green, University of Sussex
Metabolic activation:
with and without
Metabolic activation system:
rat liver S9 (Arcoclor 1254 induced)
Test concentrations with justification for top dose:
0.2, 2, 20, 500 and 2000 μg/plate
Vehicle / solvent:
water
Controls
Untreated negative controls:
not specified
Positive controls:
yes
Positive control substance:
4-nitroquinoline-N-oxide
7,12-dimethylbenzanthracene
sodium azide
benzo(a)pyrene
cyclophosphamide
ethylmethanesulphonate
methylmethanesulfonate
other: neutral red
Details on test system and experimental conditions:
METHOD OF APPLICATION:
- plate-incorporation assay: in medium; in agar; according to method described by Ames et al. (1975)
- pre-incubation assay: in agar, according to method described by Brooks and Dean (1981)
- spot test: test compound added to a 1-cm diameter sterile filter disc before adding to the centre of the seeded plate; according to method described by Ames et al., (1975)
- treat-and-plate method: overnight broth cultures

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium, other: TA 98, TA 100, TA 1535, TA 1537, TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Positive controls validity:
not specified
Species / strain:
E. coli, other: WP2 an WP2 uvrA
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Positive controls validity:
not specified

Applicant's summary and conclusion

Conclusions:
The in vitro genotoxic potential of 2-aminoethanol in bacteria was investigated in two species: (1) Salmonella typhimurium TA1535, TA1537, TA1538, TA98 and TA100; and (2) Escherichia coli WP2 and WP2 uvrA. In both species, negative results were reported for 2-aminoethanol with and without activation.